510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K011916Substantially Equivalent

Super C Hemodialysis/apheresis Chronic Catheter, Model Dc-36 Series, Dc-40 Series, Dc-45 Series

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

K011916 is the FDA 510(k) clearance record for SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES, a class II device, cleared for Horizon Medical Products, Inc. on under FDA product code MSD (Catheter, Hemodialysis, Implanted). FDA records list 1,110 510(k) clearances for Boston Scientific Corporation, from to . As of , FDA records show no recalls naming K011916.

Clearance record

Decision date
Received
(133 days to decision)
Product code
MSD Catheter, Hemodialysis, Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Horizon Medical Products, Inc. 1 Horizon Way, Manchester GA
510(k) summary
Summary
Third party review
No

Clearances, product code MSD

Trailing 12 months

FDA records hold no clearances under product code MSD in the trailing twelve months.

FDA records show no clearances under product code MSD in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSD, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260