510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010189Substantially Equivalent

Vortex Access System

Boston Scientific Corporation, Manchester GA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K010189 is the FDA 510(k) clearance record for VORTEX ACCESS SYSTEM, a class II device, cleared for Horizon Medical Products, Inc. on under FDA product code LJT (Port & Catheter, Implanted, Subcutaneous, Intravascular). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show 2 recalls naming K010189.

Clearance record

Decision date
Received
(21 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
Horizon Medical Products, Inc. 1 Horizon Way, Manchester GA
510(k) summary
Statement
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