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FDA 510(k)

CORDIS HAKIM ASCITES VALVE SYSTEM

K-Number: K803258 · 1981-01-15

ApplicantCordis Corp.
Decision Date1981-01-15
Product CodeKPM
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CORDIS HAKIM ASCITES VALVE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cordis Corp.. It received FDA 510(k) clearance on 1981-01-15 under 510(k) number K803258. 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 CORDIS HAKIM ASCITES VALVE SYSTEM?

CORDIS HAKIM ASCITES VALVE SYSTEM is a medical device that received FDA 510(k) clearance on 1981-01-15. The listed applicant is Cordis Corp.. The 510(k) number is K803258.

When did CORDIS HAKIM ASCITES VALVE SYSTEM receive FDA 510(k) clearance?

CORDIS HAKIM ASCITES VALVE SYSTEM received FDA 510(k) clearance on 1981-01-15, under 510(k) number K803258.

Who is the listed applicant for CORDIS HAKIM ASCITES VALVE SYSTEM?

The FDA 510(k) record lists Cordis Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CORDIS HAKIM ASCITES VALVE SYSTEM?

The FDA product code for CORDIS HAKIM ASCITES VALVE SYSTEM is KPM.

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Other records listing Cordis Corp. as applicant

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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.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.

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