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Catheter Introducer

by Angeion Corp.

510(k) K871153

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 NumberK871153 Date24 Jun 1987ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0345-06 FDA Unclassified (pre-2012) initiated 13 Sep 2005

    Sheath size is larger than dilator size causing insertion difficulties.

    • Terminated Z-1062-05 FDA Unclassified (pre-2012) initiated 27 May 2005

    Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.

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  • Withdrawn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
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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