Skip to content

VENA TECH VENA CAVA FILTER - Vena Tech Vena Cava Filter

by Bbraun

510(k) K010485

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK010485 Date18 May 2001ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0264-2008 FDA Unclassified (pre-2012) initiated 30 Oct 2007

    Sterility (package integrity) compromised: package sealing problem leaving packaging being partially open on one of the four sealed Tyvek pouch edges.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTK
Models / Variants
Vena Tech Vena Cava Filter
Device Class
Class II
Regulation
21 CFR Part 870.3375
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent