FDA 510(k)

DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER

K-Number: K012235 · 2001-10-04

Decision Date2001-10-04

Product CodeKPM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedical, Inc.. It received FDA 510(k) clearance on 2001-10-04 under 510(k) number K012235. The device is classified under product code KPM. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER?

DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER is a medical device that received FDA 510(k) clearance on 2001-10-04. The listed applicant is Denver Biomedical, Inc.. The 510(k) number is K012235.

When did DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER receive FDA 510(k) clearance?

DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER received FDA 510(k) clearance on 2001-10-04, under 510(k) number K012235.

Who is the listed applicant for DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER?

The FDA 510(k) record lists Denver Biomedical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER?

The FDA product code for DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER is KPM.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Denver Biomedical, Inc. as applicant

K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS K052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000 K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT K011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS

Related Devices (Code: KPM)

K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.K170405BD Curve Ascites ShuntCare Fusion K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTDenver Biomedical, Inc.K011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedicals, Inc.K003451DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES TDenver Biomedicals, Inc.K973129DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITSDenver Biomaterials, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.