Skip to content

Trimport

by Gerard Medical Enterprises, Inc. 2 variants

510(k) K942623

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

7 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 NumberK942623 Date23 Aug 1994ClearedStatusActive

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-1882-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1886-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1885-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1887-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1881-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1883-2010 FDA Unclassified (pre-2012) initiated 13 May 2010
    • Terminated Z-1884-2010 FDA Unclassified (pre-2012) initiated 13 May 2010

    FDA testing determined that non-coring needles included in the Vaxcel Port and Vaxcel Port with PASV Valve may result in coring and resulting septum damage which could lead to patient injury.

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  • Withdrawn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
LJT
Device Class
Class II
Regulation
21 CFR Part 880.5965
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Other devices from Gerard Medical Enterprises, Inc.

See all devices from Gerard Medical Enterprises, Inc. →