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Cordis Avanti+catheter Sheath Introducer System

by Cordis Corp.

510(k) K970392

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 · Traditional NumberK970392 Date24 Apr 1997ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-2079-2021 FDA Class II initiated 9 Jun 2021

    The product in the packaging is larger (both inner and outer diameter) than the labeling indicates.

    • Terminated Z-1174-2016 FDA Class II initiated 31 Dec 2015

    Incorrect cannula of the sheath introducer (smaller than intended).

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  • Withdrawn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
DRE
Device Class
Class II
Regulation
21 CFR Part 870.1310
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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