510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011831Substantially Equivalent

Modification to Pleurx Pleural Catheter and Drainage Kits

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

K011831 is the FDA 510(k) clearance record for MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS, a class II device, cleared for Denver Biomedical, Inc. on under FDA product code DWM (Apparatus, Suction, Patient Care). FDA records list 5 510(k) clearances for Denver Biomedical, Inc., from to . As of , FDA records show no recalls naming K011831.

Clearance record

Decision date
Received
(16 days to decision)
Product code
DWM Apparatus, Suction, Patient Care
Regulation
21 CFR 870.5050
Device class
Class II
Review panel
Cardiovascular
Applicant
Denver Biomedical, Inc. 14998 W. 6th Ave., Bldg. E700, Golden CO
510(k) summary
Summary
Third party review
No

Clearances, product code DWM

Trailing 12 months

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

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