DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER— 510(k) K012235

Name: FDA 510(k) clearance K012235
Creator: U.S. Food and Drug Administration
Published: 2001-10-04

Substantially Equivalent

Denver Biomedical, Inc.

FDA 510(k) clearance K012235 for DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER, Substantially Equivalent on 2001-10-04. Applicant: Denver Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Denver Biomedical, Inc.
Product code: Code KPM
Device class: Class 2
Regulation: 21 CFR 876.5955
Advisory panel: Gastroenterology, Urology
Date received: 2001-07-17
Decision date: 2001-10-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Golden, CO, US

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