510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K150800Substantially Equivalent

Valved Safety Centesis Catheter

B.Braun Medical, Inc., Allentown PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K150800 is the FDA 510(k) clearance record for Valved Safety Centesis Catheter, a class I device, cleared for B.Braun Medical, Inc. on under FDA product code GCB (Needle, Catheter). FDA records list 149 510(k) clearances for B.Braun Medical, Inc., from to . As of , FDA records show no recalls naming K150800.

Clearance record

Decision date
Received
(231 days to decision)
Product code
GCB Needle, Catheter
Regulation
21 CFR 878.4200
Device class
Class I
Review panel
General, Plastic Surgery
Applicant
B.Braun Medical, Inc. 901 Marcon Blvd., Allentown PA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GCB

Trailing 12 months

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

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