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Retrograde Coronary Sinus Perfusion Cannula with Elongated & Treaded Cuff & Introducer Stylet

by Dlp, Inc.

510(k) K953945

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

8 ongoing

This device is named in the recall

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 NumberK953945 Date26 Mar 1996ClearedStatusActive

Recalls

8 recalls · 8 ongoing · FDA

  • 8 recalls, same reason

    • Ongoing Z-2218-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2219-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2216-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2214-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2217-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2221-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2222-2026 FDA Class II initiated 21 Apr 2026
    • Ongoing Z-2220-2026 FDA Class II initiated 21 Apr 2026

    Certain lots of product have the potential for a sterile barrier breach.

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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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