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Various Cardiovascular Surgical Device

by Research Industries Corp.

510(k) K831769

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

8 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 NumberK831769 Date12 Aug 1983ClearedStatusActive

Recalls

8 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-2402-2008 FDA Unclassified (pre-2012) initiated 14 Jul 2008
    • Terminated Z-2403-2008 FDA Unclassified (pre-2012) initiated 14 Jul 2008
    • Terminated Z-2401-2008 FDA Unclassified (pre-2012) initiated 14 Jul 2008

    Reinforcement spring may detach from the cannula body resulting in reduced venous blood return flow.

  • 5 recalls, same reason

    • Terminated Z-1093-06 FDA Unclassified (pre-2012) initiated 18 Apr 2006
    • Terminated Z-1091-06 FDA Unclassified (pre-2012) initiated 18 Apr 2006
    • Terminated Z-1089-06 FDA Unclassified (pre-2012) initiated 18 Apr 2006
    • Terminated Z-1092-06 FDA Unclassified (pre-2012) initiated 18 Apr 2006
    • Terminated Z-1090-06 FDA Unclassified (pre-2012) initiated 18 Apr 2006

    Due to potential embrittlement of the plastic tip which may crack or separate 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  • Withdrawn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
DWF
Device Class
Class II
Regulation
21 CFR Part 870.4210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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