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Directflow Arterial Cannula

by Heartport, Inc.

510(k) K990772

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

6 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 · Special NumberK990772 Date23 Mar 1999ClearedStatusActive

Recalls

6 recalls · FDA

    • Terminated Z-1101-06 FDA Unclassified (pre-2012) initiated 27 Apr 2006

    During cardiopulmonary bypass (CPB) the distal tip of the arterial cannula can become disconnected from the body of the cannula.

  • 5 recalls, same reason

    • Terminated Z-0307-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003
    • Terminated Z-0310-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003
    • Terminated Z-0308-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003
    • Terminated Z-0309-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003
    • Terminated Z-0311-04 FDA Unclassified (pre-2012) initiated 2 Oct 2003

    Damaged hemostasis valves that prevent or present difficulty when inserting catheters.

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  • Withdrawn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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