Home / 510(k) Clearances / K945250

510(k) K945250

TRIMPORT by Gerard Medical Enterprises, Inc. — Product Code LJT

K945250 is an FDA 510(k) premarket notification submitted by Gerard Medical Enterprises, Inc. for the device "TRIMPORT". The FDA issued a decision of Substantially Equivalent on March 7, 1995. The device falls under product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular), a Class II device regulated under 21 CFR 880.5965. Gerard Medical Enterprises, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1995
Date Received
October 28, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class
Class II
Regulation Number
880.5965
Review Panel
HO
Submission Type

Other clearances by Gerard Medical Enterprises, Inc.

  • K954258 — TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION) (May 24, 1996)
  • K942623 — TRIMPORT (August 23, 1994)
  • K922147 — DUAL PLASTIC VASCULAR ACCESS SYSTEM (December 4, 1992)
  • K913114 — TRIM-PORT(TM) IMPLANT ACCESS SYST DUAL TITAN PORT (January 2, 1992)
  • K912111 — MODIFIED VERSION IMPLANTABLE VASCULAR ACCESS SYSTE (October 8, 1991)
  • K903364 — GERARD MEDICAL, INC. TRIM-PORT (October 31, 1990)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)

Other clearances for product code LJT

  • K260916 — FLEXI-PORT™ Power Injectable Implantable Port (June 17, 2026)
  • K252478 — Vaccess™ CT Low-Profile Power-Injectable Implantable Port; Vaccess™ CT Power-Inj (September 5, 2025)
  • K251253 — PowerPort™ isp Implantable Port; PowerPort™ Slim Implantable Port; PowerPort™ M. (June 18, 2025)
  • K242328 — PowerPort™ ClearVUE™ Slim Implantable Ports and PowerPort™ ClearVUE™ Slim Implan (October 31, 2024)
  • K232737 — PowerPort™ ClearVUE™ Slim ECG Enabled Implantable Port; PowerPort™ ClearVUE™ isp (December 8, 2023)
  • K190559 — SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports (May 22, 2020)
  • K181446 — Bard Power-Injectable Implantable Ports (PowerPorts®) (July 8, 2019)
  • K151239 — NMI DUAL PORT II (June 6, 2016)
  • K153359 — BardPort®, SlimPort®, and X-Port® Implanted Ports (May 20, 2016)
  • K153238 — Dignity Dual Port (March 15, 2016)

FDA data resources