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Clarivein Catheter

by Vascular Insights, LLC

510(k) K071468

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Abbreviated NumberK071468 Date20 Mar 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1146-2018 FDA Class II initiated 9 Nov 2017

    Certain catheters could have a compromised catheter shaft due to a manufacturing defect which could result in some delamination of the catheter shaft including during introduction of the catheter into a vascular access introducer.

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  • Withdrawn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
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Vascular Insights, LLC

  • ClariVein IC

    Class II