510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K964538Substantially Equivalent

R-Port Standard Implantable Vascular Access System

Boston Scientific Corporation, Natick, MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964538 is the FDA 510(k) clearance record for R-PORT STANDARD IMPLANTABLE VASCULAR ACCESS SYSTEM, a class II device, cleared for Boston Scientific Corp on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 1,110 510(k) clearances for Boston Scientific Corp, from to . As of , FDA records show no recalls naming K964538.

Clearance record

Decision date
Received
(118 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
Boston Scientific Corp One Boston Scientific Pl., Natick, 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 November 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LJT, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260
November 20260