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HEPARIN LOCK FLUSH SOLUTION USP - 504401

by App Pharmaceuticals, LLC

510(k) K092938

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Traditional NumberK092938 Date18 Jun 2010ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1032-2015 FDA Class II initiated 19 Dec 2014

    The lot failed pH specification.

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  • Withdrawn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
NZW
Models / Variants
504401
Device Class
Class II
Regulation
21 CFR Part 880.5200
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent