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FDA 510(k)

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS

K-Number: K902475 · 1990-12-03

ApplicantCardio-Pak
Decision Date1990-12-03
Product CodeDXT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS is the device name listed in this FDA 510(k) record. The listed applicant is Cardio-Pak. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K902475. The device is classified under product code DXT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS?

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Cardio-Pak. The 510(k) number is K902475.

When did CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS receive FDA 510(k) clearance?

CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS received FDA 510(k) clearance on 1990-12-03, under 510(k) number K902475.

Who is the listed applicant for CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS?

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

What is the FDA product code for CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS?

The FDA product code for CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS is DXT.

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Related Devices (Code: DXT)

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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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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