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FDA 510(k)

CARDIOPLEGIA SOLUTION ADMIN. SET

K-Number: K792152 · 1979-11-13

Decision Date1979-11-13
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPLEGIA SOLUTION ADMIN. SET is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Systems, Inc.. It received FDA 510(k) clearance on 1979-11-13 under 510(k) number K792152. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOPLEGIA SOLUTION ADMIN. SET?

CARDIOPLEGIA SOLUTION ADMIN. SET is a medical device that received FDA 510(k) clearance on 1979-11-13. The listed applicant is Cardio Systems, Inc.. The 510(k) number is K792152.

When did CARDIOPLEGIA SOLUTION ADMIN. SET receive FDA 510(k) clearance?

CARDIOPLEGIA SOLUTION ADMIN. SET received FDA 510(k) clearance on 1979-11-13, under 510(k) number K792152.

Who is the listed applicant for CARDIOPLEGIA SOLUTION ADMIN. SET?

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

What is the FDA product code for CARDIOPLEGIA SOLUTION ADMIN. SET?

The FDA product code for CARDIOPLEGIA SOLUTION ADMIN. SET is DWF.

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.

Other records listing Cardio Systems, 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.

View all 9 devices →

Related Devices (Code: DWF)

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.

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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