Skip to content

18 Fr. Rmi Arterial Perfusion Cannula II, 20 Fr. Rmi Arterial Perfusion Cannula II

by Edwards Lifesciences Research Medical

510(k) K073559

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 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 · Special NumberK073559 Date31 Jan 2008ClearedStatusActive

Recalls

3 recalls · 2 ongoing · FDA

  • 2 recalls, same reason

    • Ongoing Z-2081-2025 FDA Class I initiated 14 May 2025
    • Ongoing Z-2080-2025 FDA Class I initiated 14 May 2025

    due to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body.

    • Terminated Z-3034-2018 FDA Class II initiated 7 Mar 2018

    The expiration date on the device labeling exceeds its actual validated shelf life because the sterilization process used does not have adequate support for the extended shelf life.

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  • Withdrawn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
DQR
Device Class
Class II
Regulation
21 CFR Part 870.1300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Edwards Lifesciences Research Medical