510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K954258Substantially Equivalent

Trimport Implantable Access System (Modification)

Gerard Medical Enterprises, Inc., Charlton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954258 is the FDA 510(k) clearance record for TRIMPORT IMPLANTABLE ACCESS SYSTEM (MODIFICATION), a class II device, cleared for Gerard Medical Enterprises, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 8 510(k) clearances for Gerard Medical Enterprises, Inc., from to . As of , FDA records show 12 recalls naming K954258.

Clearance record

Decision date
Received
(262 days to decision)
Product code
LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Regulation
21 CFR 880.5965
Device class
Class II
Review panel
General Hospital
Applicant
Gerard Medical Enterprises, Inc. 90 Worcester Rd., Charlton MA
510(k) summary
Summary
Third party review
No

Clearances, product code LJT

Trailing 12 months
1 clearance under product code LJT in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260