510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K952660Substantially Equivalent

Braun Hemodialysis Catheter

B.Braun Medical, Inc., So. San Francisco CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952660 is the FDA 510(k) clearance record for BRAUN HEMODIALYSIS CATHETER, a class II device, cleared for B.Braun Medical, Inc. on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K952660.

Clearance record

Decision date
Received
(463 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
B.Braun Medical, Inc. 805 Grandview Dr., So. San Francisco CA
510(k) summary
Summary
Third party review
No

Clearances, product code MPB

Trailing 12 months

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

FDA records show no clearances under product code MPB in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPB, 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