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Sarns Cardioplegia/Vent Catheters

by 3M Health Care, Sarns

510(k) K873212

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

20 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 NumberK873212 Date6 Nov 1987ClearedStatusActive

Recalls

20 recalls · FDA

  • 20 recalls, same reason

    • Terminated Z-1886-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1893-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1882-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1894-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1881-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1887-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1889-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1891-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1888-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1883-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1880-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1876-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1877-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1885-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1884-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1878-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1890-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1892-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1879-2012 FDA Class II initiated 9 May 2012
    • Terminated Z-1875-2012 FDA Class II initiated 9 May 2012

    During production of the Sarns Antegrade Cardioplegia Cannula, Terumo Cardiovascular Systems (Terumo CVS) identified the presence of a foreign substance on the inner surface of some cannulae tips. 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

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  • Withdrawn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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