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510(k) K003446

SYMMETRY AORTIC CLIP SYSTEM by St. Jude Medical Cardiovascular Group, Inc. — Product Code NCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 2001
Date Received
November 6, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)
Device Class
Class II
Regulation Number
878.4300
Review Panel
SU
Submission Type

Other clearances for product code NCA

  • K013664 — COALESCENT SURGICAL U-CLIP (January 24, 2002)
  • K011589 — CORLINK AAD (3.5 TO 6.0 M M OUTER DIAMETER VESSELS),MODEL 200-064, CORLINK AAD ( (December 26, 2001)