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FDA 510(k)

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI

K-Number: K832124 · 1983-08-12

Decision Date1983-08-12
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI is the device name listed in this FDA 510(k) record. The listed applicant is Med-West, Inc.. It received FDA 510(k) clearance on 1983-08-12 under 510(k) number K832124. 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 CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI?

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI is a medical device that received FDA 510(k) clearance on 1983-08-12. The listed applicant is Med-West, Inc.. The 510(k) number is K832124.

When did CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI receive FDA 510(k) clearance?

CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI received FDA 510(k) clearance on 1983-08-12, under 510(k) number K832124.

Who is the listed applicant for CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI?

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

What is the FDA product code for CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI?

The FDA product code for CPC, COUBLE LUMEN CARDIOPLEGIA-AIR ASPI 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 Med-West, 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 11 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

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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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