510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051711Substantially Equivalent

Pleurx Peritoneal Catheter Kit and Pleurx Drainage Kits

Denver Biomedical, Inc., Golden CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051711 is the FDA 510(k) clearance record for PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS, a class II device, cleared for Denver Biomedical, Inc. on under FDA product code PNG (Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling). FDA's definition for product code PNG reads: "For drainage of refractory ascites with long-term occurrence from the peritoneal cavity". FDA records list 5 510(k) clearances for Denver Biomedical, Inc., from to . As of , FDA records show no recalls naming K051711.

Clearance record

Decision date
Received
(141 days to decision)
Product code
PNG Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
Regulation
21 CFR 876.5630
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Denver Biomedical, Inc. 433 Park Pt. Dr., Suite 140, Golden CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNG

Trailing 12 months

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

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