510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K040301Unknown

Gamcath High Flow Catheter, Ref: Gdhk 13Xx a

Gambro Renal Products, Lakewood CO / Traditional, Unknown
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040301 is the FDA 510(k) clearance record for GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A, a class II device, cleared for Gambro Renal Products on under FDA product code MPB (Catheter, Hemodialysis, Non-Implanted). FDA records list 37 510(k) clearances for Gambro Renal Products, from to . As of , FDA records show no recalls naming K040301.

Clearance record

Decision date
Received
(266 days to decision)
Product code
MPB Catheter, Hemodialysis, Non-Implanted
Regulation
21 CFR 876.5540
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Gambro Renal Products 10810 W Collins Ave., Lakewood CO
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MPB, 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