510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011862Substantially Equivalent

Denver Ascites Shunt and Percutaneous Access Kit with Ascities Shunt

Denver Biomedical, Inc., Golden CO / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011862 is the FDA 510(k) clearance record for DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT, a class II device, cleared for Denver Biomedical, Inc. on under FDA product code KPM (Shunt, Peritoneal). FDA records list 5 510(k) clearances for Denver Biomedical, Inc., from to . As of , FDA records show no recalls naming K011862.

Clearance record

Decision date
Received
(28 days to decision)
Product code
KPM Shunt, Peritoneal
Regulation
21 CFR 876.5955
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700, Golden CO
510(k) summary
Summary
Third party review
No

Clearances, product code KPM

Trailing 12 months

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

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