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Arrow Rediguard, 9FR. 50cc, Intra-Aortic Balloon Vatheter, Iab-R950-U

by Arrow Intl., Inc.

510(k) K010330

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

13 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK010330 Date2 Mar 2001ClearedStatusActive

Recalls

13 recalls · FDA

  • 13 recalls, same reason

    • Terminated Z-1212-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1218-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1216-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1210-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1220-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1214-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1213-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1211-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1217-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1219-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1215-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1221-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009
    • Terminated Z-1222-2009 FDA Unclassified (pre-2012) initiated 2 Feb 2009

    A fault in the connector of the pump tubing assembly may result in the volume setting on the pump defaulting to 2.5 ccs or 5 ccs (depending on IABP model) rather than the appropriate 30, 40, or 50 cc volume.

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  • Withdrawn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
DSP
Device Class
Class II
Regulation
21 CFR Part 870.3535
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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