Cleared Special

K093903 - ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC
(FDA 510(k) Clearance)

K093903 · Genesee Biomedical, Inc. · Cardiovascular

Jul 2010

Decision

205d

Days

Class 2

Risk

K093903 is an FDA 510(k) clearance for the ATS TRI-AD SEMI-FLEXIBLE TRICUSPID ANUULOPLASTY, MODEL 900SFC. This device is classified as a Ring, Annuloplasty (Class II — Special Controls, product code KRH).

Submitted by Genesee Biomedical, Inc. (Denver, US). The FDA issued a Cleared decision on July 15, 2010, 205 days after receiving the submission on December 22, 2009.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.3800.

Submission Details

510(k) Number	K093903 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 2009
Decision Date	July 15, 2010
Days to Decision	205 days
Submission Type	Special
Review Panel	Cardiovascular (CV)
Summary	Summary PDF