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Flowmedica Bifurcated Infusion System, Infusion Catheter and Introducer Sheath

by Flowmedica, Inc.

510(k) K033569

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 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 NumberK033569 Date13 Jan 2004ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1734-2010 FDA Unclassified (pre-2012) initiated 30 Apr 2010
    • Terminated Z-1733-2010 FDA Unclassified (pre-2012) initiated 30 Apr 2010

    Benephit Infusion Catheters may exhibit a hole or tear in the primary sterile barrier packaging. The product is intended to be sterile. Breaches in the sterile packaging may result in non-sterile product, which could potentially cause a patient infection which is a serious medical condition.

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  • Withdrawn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
KRA
Device Class
Class II
Regulation
21 CFR Part 870.1210
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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