Home / 510(k) Clearances / K922147

510(k) K922147

DUAL PLASTIC VASCULAR ACCESS SYSTEM by Gerard Medical Enterprises, Inc. — Product Code LJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 4, 1992
Date Received
May 7, 1992
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)
  • K945250 — TRIMPORT (March 7, 1995)
  • K942623 — TRIMPORT (August 23, 1994)
  • 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

  • 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)
  • K153228 — NMI Port, NMI Port II (December 4, 2015)