Cook celect platinum ivc filter

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August undefined, 2024

WebCook Medical Inc retrievable cook celect platinum ivc filter Retrievable Cook Celect Platinum Ivc Filter, supplied by Cook Medical Inc, used in various techniques. Bioz … Webfilter, intravascular, cardiovascular. 22. 510 (k) Number. K171712. Device Name. Cook Celect Platinum Vena Cava Filter Set for Femoral Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Jugular Vein Approach, Cook Celect Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach. Applicant.

The Celect Platinum Inferior Vena Cava Filter

WebJan 27, 2014 · Grade 2: Filter strut is entirely outside of the IVC lumen and within the retroperitoneum as evidenced by a "halo" of retroperitoneal fat around axially viewed strut. Grade 3: Filter strut is touching, impressing, or perforating another organ (e.g., liver, bowel, aorta, psoas muscle, vertebral body, lymph nodes). WebThe Celect Platinum can be used as either a permanent or a retrievable device. Its secondary strut design is intended to help center the filter during placement, while its specially designed anchors allow for secure, … blade and sorcery u10 torrent

Cook Medical G34502 - McKesson Medical-Surgical

WebOct 28, 2024 · Brand Name: Cook Celect. Version or Model: G34309. Commercial Distribution Status: In Commercial Distribution. Catalog Number: IGTCFS-65-1-JUG-CELECT-PT. Company Name: William Cook Europe ApS. Primary DI Number: 10827002343099. Issuing Agency: GS1. Commercial Distribution End Date: Device … WebJul 10, 2024 · It was the best of filters – so the manufacturer claimed. It turned out to be the worst of filters. An early study involving the Cook Celect Vena Cava Filter indicated the device was incredible. Another … WebTo evaluate the safety of retrieving the Cook Celect Vena Cava Filter, a clinical study was conducted in which filter retrieval was attempted in 43 patients (12 female, 31 male), and 41 retrievals were successful. Time to retrieval ranged from 1-67 weeks. See the Kaplan-Meier graph depicting success over time for retrieval of Celect filter ... fpc hughesville pa

Class 3 Device Recall Cook Celect Platinum Vena Cava Filter Set

WebSep 24, 2024 · The Celect Platinum is designed to prevent recurrent pulmonary embolism (PE) via placement in the inferior vena cava. The Celect Platinum can be used as either a permanent or a retrievable device. When is the Cook CELECT platinum filter implant used for PE? • Chronic, recurrent PE where anticoagulant therapy has failed or is … WebG34505: Cook Celect Platinum Vena Cava Filter, UniSet. In-Date » Cook » Vena Cava. Photos are for illustration purposes only and may not depict the exact item. ... Celect® … blade and sorcery u10 bugsWebThe Celect Platinum vena cava filter (Cook) received initial FDA approval in 2012 and includes a design change to the four anchoring legs . The most common complication with the Günther Tulip and Celect IVC filters is IVC perforation, which occurred with 86% of filters evaluated as part of a retrospective review up to 880 days after placement ... fpc hotbar

"WebCook Platinum. To replace the dangerous Celect, Cook introduced the Platinum. We now know this device also has serious problems, including migration, fracture, perforation and embedding in the vena cava. This filter is relatively new, so its effects on many patients are yet to be seen. However, many Platinum IVC filter lawsuits have already ... " - Cook celect platinum ivc filter

Cook celect platinum ivc filter

510(k) Premarket Notification - Food and Drug Administration

WebConsequently, physicians are advised to remove IVC filters as soon as they become unnecessary in order to avoid these IVC filter complications. 2. 4. Recalled Cook IVC filters. Currently, the FDA is recalling the Celect Platinum Vena Cava Filter Set for Jugular Vein Approach for labeling problems. This is likely a temporary recall until the ... WebThe following information is alleged: the patient received a celect platinum (pt) inferior vena cava (ivc) filter on (b)(6) 2024, and an attempted filter retrieval was performed approximately 2 months after receiving the implant which failed due to blood clots in and around the ivc filter.

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WebG34502: Cook Celect Platinum Vena Cava Filter, Femoral (No Box) In-Date » Cook » Vena Cava. Photos are for illustration purposes only and may not depict the exact item. ... Celect® Vena Cava Filter G34502 / IGTCFS-65-1-FEM-CELECT-PT. Filter Maximum Diameter: 30mm; Filter Length: 49mm; Introducer Sheath: 7F; WebFeb 25, 2024 · The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: Pulmonary thromboembolism when anticoagulant therapy is contraindicated; Failure of anticoagulant therapy in thromboembolic diseases; Emergency treatment …

WebThe Cook Celect Platinum Vena Cava Filter was designed as a temporary filter to prevent pulmonary embolisms in those who are unable to take standard blood-thinning … WebIGTCFS-65 -2-UNI-CELECT-PT G34504 Cook Celect® Platinum Vena Cava Filter Set for Femoral and Jugular Vein Approach Nil ; Page 1 of 1 Acknowledgement and Receipt Form Please reply to this notification within 5 business days of receipt, even if you do not have any affected product.

WebWe are providing free consultations and claim evaluations to all individuals who received an IVC filter since 2003, who suspect that they may have experienced problems from a fractured Cook Gunther Tulip and Celect … WebOct 28, 2024 · Brand Name: Cook Celect. Version or Model: G34502. Commercial Distribution Status: In Commercial Distribution. Catalog Number: IGTCFS-65-1-FEM …

WebCelect™ Platinum Vena Cava Filter. Specifications Videos Documents Images. Used for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following situations: • Pulmonary …

WebFeb 25, 2024 · The Cook Celect Platinum Filter implant is intended for the prevention of recurrent pulmonary embolism (PE) via placement in the vena cava in the following … blade and sorcery u10 mod the outer rimWebBackground: The purpose of this study was to retrospectively assess the retrieval characteristics and rate of filter-related complications associated with use of the Celect … fpc industry \u0026 enterpriseWebCook Celect Platinum Vena Cava Filter Set is available in a Femoral Set and a Jugular Set. Each Set consists of a preloaded filter, a coaxial introducer sheath system, a … fpc industry \\u0026 enterpriseWebOct 22, 2012 · In nonclinical testing, the Cook Celect Vena Cava Filter produced a maximum temperature change of 3.7 °C during 15 minutes of MRI (i.e., for one scanning sequence) performed in a 1.5 tesla MR system (1.5 tesla/64 MHz, Siemens Magnetom Avanto®, Numaris/4 syngo® MR B17) at an MR system-reported whole-body-averaged … blade and sorcery u10 mapsWebThe Cook Celect Platinum Vena Cava Filter was designed as a temporary filter to prevent pulmonary embolisms in those who are unable to take standard blood-thinning medication. Although designed to maintain rigidness and stability, the filter is prone to fail due to production errors. fpc in indiaWebThe subject Cook Celect® Platinum Vena Cava Filter Sets are substantially equivalent to the predicate devices (K171712). No changes have been made to the IVC filter implant or the delivery systems. Only the device labeling has been updated based on post-market surveillance information fpc implies 100% sampling in some strataWebResults: Total of 357 patients (age 18-95, Male: 231) underwent IVC filter retrieval, comprising of Cook Celect Platinum, Cook Celect, and ALN-branded filters. Of these 182 patients were on anticoagulation and 175 patients were not on anticoagulation, based on the indication for the filter (thrombosis or prophylaxis) and at the discretion of ... fpc in borger