Percutaneous Introducer for Vena Cava Filter Syst
by B. Braun Vena-Tech 510(k)
Active
510(k) K932921
Overview
The Percutaneous Introducer for Vena Cava Filter System is a medical device classified as an intravascular filter, designed for cardiovascular use. It serves as a conduit for the placement of vena cava filters, which are implanted to prevent pulmonary embolism by capturing thrombi within the inferior vena cava. This device facilitates the delivery of filters in procedures requiring vascular access, ensuring proper positioning and deployment.
This device is intended for single-use in interventional radiology or cardiology procedures, where it aids in the percutaneous insertion of vena cava filters. Supplied sterile, it is regulated under FDA 510(k) clearance (K932921) as substantially equivalent to existing devices in the cardiovascular category. The introducer is compatible with standard vascular access techniques and adheres to regulatory standards for Class II medical devices, including compliance with FDA regulation number 870.3375. Storage and handling follow sterile medical device protocols to maintain integrity until use.
Percutaneous Introducer for Vena Cava Filter System
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK932921 | Date30 Aug 1993 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 5 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTK
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3375
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from B. Braun Vena-Tech
Questions
What is the Percutaneous Introducer for Vena Cava Filter System used for?
This device is designed as a conduit for the percutaneous insertion of vena cava filters during interventional radiology or cardiology procedures. Its primary purpose is to facilitate the accurate delivery and positioning of filters within the inferior vena cava, helping to prevent pulmonary embolism by capturing thrombi.
Is the introducer intended for single-use or reuse?
The device is explicitly intended for single-use only. This ensures sterility and safety during procedures, as reuse could compromise its integrity and introduce infection risks. Always follow the manufacturer’s guidelines for proper disposal after use.
How is the introducer supplied and what sterility standards apply?
The introducer is supplied sterile, packaged to maintain its integrity until use. Sterility is critical for intravascular devices to prevent contamination during procedures. Always check the packaging for sterility indicators before use and adhere to sterile medical device handling protocols.
What regulatory pathway does this device follow?
The device is regulated under the FDA’s 510(k) clearance pathway, specifically classified as substantially equivalent to existing cardiovascular devices. It holds clearance number K932921 and complies with FDA regulation number 870.3375, ensuring it meets Class II medical device standards for safety and performance.
How should the introducer be stored before use?
Storage must follow sterile medical device protocols to preserve the device’s integrity. Keep it in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the packaging remains sealed until immediately before use.