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FDA 510(k)

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC

K-Number: K093903 · 2010-07-15

ApplicantGenesee Biomedical, Inc.
Decision Date2010-07-15
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC is the device name listed in this FDA 510(k) record. The listed applicant is Genesee Biomedical, Inc.. It received FDA 510(k) clearance on 2010-07-15 under 510(k) number K093903. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC?

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC is a medical device that received FDA 510(k) clearance on 2010-07-15. The listed applicant is Genesee Biomedical, Inc.. The 510(k) number is K093903.

When did ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC receive FDA 510(k) clearance?

ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC received FDA 510(k) clearance on 2010-07-15, under 510(k) number K093903.

Who is the listed applicant for ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC?

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

What is the FDA product code for ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC?

The FDA product code for ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC is KRH.

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Related Devices (Code: KRH)

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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