Federal Register #FDA2026N3946

FDA Classifies Laser-Powered IVC Filter Retrieval Catheter as Class II Medical Device

The Food and Drug Administration (FDA), part of the Department of Health and Human Services, has issued a final regulatory order classifying the laser-powered inferior vena cava (IVC) filter retrieval catheter as a Class II medical device with special controls. - Government Buyer: - Department of Health and Human Services - Food and Drug Administration (FDA) - OEMs and Vendors: - Spectranetics, Inc. (submitted De Novo classification request for the CavaClear Laser Sheath) - Products/Devices: - Laser-powered inferior vena cava filter retrieval catheter - Part number: 870.5125 - Description: Percutaneous catheter using laser ablation to detach and remove indwelling IVC filters - Notable Requirements: - Device must meet special controls including: - Clinical and non-clinical performance testing - Compatibility testing - Biocompatibility - Sterility - Labeling - User training - Device requires premarket notification (510(k)) - Purpose of Classification: - Ensure safety and effectiveness - Reduce regulatory burden - Enhance patient access to innovative devices - No procurement or solicitation for products or services is announced in this notice.

Description

The Food and Drug Administration (FDA) is classifying the laser-powered inferior vena cava filter retrieval catheter into class II (special controls). This device is a percutaneous catheter that uses a laser to ablate tissue and is intended to facilitate the detachment and removal of indwelling inferior vena cava (IVC) filters. The classification into class II provides reasonable assurance of safety and effectiveness and aims to enhance patient access to innovative devices by reducing regulatory burdens. The special controls include clinical and non-clinical performance testing, compatibility testing, biocompatibility, sterility, labeling, and training requirements.

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