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FDA 510(k)

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT

K-Number: K011862 · 2001-07-12

ApplicantDenver Biomedical, Inc.
Decision Date2001-07-12
Product CodeKPM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT 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 2001-07-12 under 510(k) number K011862. 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 SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT?

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT is a medical device that received FDA 510(k) clearance on 2001-07-12. The listed applicant is Denver Biomedical, Inc.. The 510(k) number is K011862.

When did DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT receive FDA 510(k) clearance?

DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT received FDA 510(k) clearance on 2001-07-12, under 510(k) number K011862.

Who is the listed applicant for DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT?

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 ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT?

The FDA product code for DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNT 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.

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Other records listing Denver Biomedical, Inc. as applicant

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.

K051711PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITSK052436PLEURX PLEURAL CATHETER KIT, MODEL 50-7000K012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK011831MODIFICATION TO PLEURX PLEURAL CATHETER AND DRAINAGE KITS

Related Devices (Code: KPM)

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.

K231096Automatic Continuous Effusion Shunt (ACES) System ACES SystemPleural Dynamics, Inc.K170405BD Curve Ascites ShuntCare FusionK012235DENVER PLEURAL EFFUSION SHUNT AND DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver 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

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

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