FDA 510(k)

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS

K-Number: K973129 · 1998-03-17

Decision Date1998-03-17

Product CodeKPM

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomaterials, Inc.. It received FDA 510(k) clearance on 1998-03-17 under 510(k) number K973129. 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 ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS?

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Denver Biomaterials, Inc.. The 510(k) number is K973129.

When did DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS receive FDA 510(k) clearance?

DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS received FDA 510(k) clearance on 1998-03-17, under 510(k) number K973129.

Who is the listed applicant for DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS?

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

What is the FDA product code for DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS?

The FDA product code for DENVER ASCITES SHUNTS, DENVER ASCITES SHUNT PERCUTANEOUS ACCESS KITS 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 Biomaterials, Inc. as applicant

K971753DENVER PLEURX PLEURAL CATHETER KIT, CATALOG NO. 50-7000, DENVER PLEURX HOME DRAINAGE KIT, CATALOG NO. 50-7500 K962814DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBER K960456DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY

Related Devices (Code: KPM)

K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.K170405BD Curve Ascites ShuntCare Fusion K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver Biomedical, Inc.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.

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.