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FDA 510(k)

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T

K-Number: K003451 · 2001-01-02

ApplicantDenver Biomedicals, Inc.
Decision Date2001-01-02
Product CodeKPM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T is the device name listed in this FDA 510(k) record. The listed applicant is Denver Biomedicals, Inc.. It received FDA 510(k) clearance on 2001-01-02 under 510(k) number K003451. 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 PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T?

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T is a medical device that received FDA 510(k) clearance on 2001-01-02. The listed applicant is Denver Biomedicals, Inc.. The 510(k) number is K003451.

When did DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T receive FDA 510(k) clearance?

DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T received FDA 510(k) clearance on 2001-01-02, under 510(k) number K003451.

Who is the listed applicant for DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T?

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

What is the FDA product code for DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T?

The FDA product code for DENVER PAK W/ DOUBLE-VALVE ASCITES SHUNT,DENVER PAK W/ SINGLE-VALVED ASCITES SHUNT, DENVER PAK, DOUBLED-VALVED ASCITES T is KPM.

Related Clinical Trials

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Other records listing Denver Biomedicals, 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.

K051084DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINEK011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERK010642PLEURX PLEURAL CATHETER AND DRAINAGE KITSK943968TUNNELERK913728DENVER(R) PERITONEO-SUBCLAVIAN SHUNTK842139THE DENVER PLEURAL-PERITONEAL SHUNT

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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.K011862DENVER ASCITES SHUNT AND PERCUTANEOUS ACCESS KIT WITH ASCITIES SHUNTDenver Biomedical, Inc.K011020DENVER PLEURAL EFFUSION SHUNT WITH EXTERNAL PUMP CHAMBERDenver 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.

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