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510(k) K903364

GERARD MEDICAL, INC. TRIM-PORT by Gerard Medical Enterprises, Inc. — Product Code LJT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
October 31, 1990
Date Received
July 26, 1990
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)
  • 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)
  • K813358 — GERARD MEDICAL ELECTRODE TESTER (December 29, 1981)

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  • 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)