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Cannulae, Aortic, Arch, High Flow

by 3M Health Care, Sarns

510(k) K770429

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

12 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 NumberK770429 Date16 Mar 1977ClearedStatusActive

Recalls

12 recalls · FDA

  • 6 recalls, same reason

    • Terminated Z-0669-2013 FDA Class II initiated 7 Jan 2013
    • Terminated Z-0670-2013 FDA Class II initiated 7 Jan 2013
    • Terminated Z-0668-2013 FDA Class II initiated 7 Jan 2013
    • Terminated Z-0671-2013 FDA Class II initiated 7 Jan 2013
    • Terminated Z-0667-2013 FDA Class II initiated 7 Jan 2013
    • Terminated Z-0666-2013 FDA Class II initiated 7 Jan 2013

    Flexible Arterial Cannula and High-Flow Aortic Arch Cannula connectors were identified to contain flash on the exterior of the cannula connector that exceeded established specifications. Because the flash has the potential to detach in the operative field, TCVS has decided to remove all affected lots that were manufactured with the affected connector part.

  • 6 recalls, same reason

    • Terminated Z-1840-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1833-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1841-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1832-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1842-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1839-2012 FDA Class II initiated 9 May 2012

    During production of one lot of the Sarns High-Flow Aortic Arch Cannula, Terumo Cardiovascular Systems (Terumo CVS) found a foreign substance on the outer surface of some cannulae connectors. Terumo CVS' preliminary investigation found that the substance can be dislodged from the cannula surface, the substance was likely deposited during the molding process, but the exact composition of the parti

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  • Withdrawn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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