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BIFLEX(TM) ANNULOPLASTY RING

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902159
510(k) Type
Traditional
Applicant
ST. JUDE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/1991
Days to Decision
248 days

BIFLEX(TM) ANNULOPLASTY RING

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K902159
510(k) Type
Traditional
Applicant
ST. JUDE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
1/18/1991
Days to Decision
248 days