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FDA 510(k)

UNI-GRAFT K DV

K-Number: K963790 · 1997-07-21

ApplicantAtrium Medical Corp.
Decision Date1997-07-21
Product CodeDSY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

UNI-GRAFT K DV is the device name listed in this FDA 510(k) record. The listed applicant is Atrium Medical Corp.. It received FDA 510(k) clearance on 1997-07-21 under 510(k) number K963790. The device is classified under product code DSY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UNI-GRAFT K DV?

UNI-GRAFT K DV is a medical device that received FDA 510(k) clearance on 1997-07-21. The listed applicant is Atrium Medical Corp.. The 510(k) number is K963790.

When did UNI-GRAFT K DV receive FDA 510(k) clearance?

UNI-GRAFT K DV received FDA 510(k) clearance on 1997-07-21, under 510(k) number K963790.

Who is the listed applicant for UNI-GRAFT K DV?

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

What is the FDA product code for UNI-GRAFT K DV?

The FDA product code for UNI-GRAFT K DV is DSY.

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Other records listing Atrium Medical Corp. 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.

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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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