510(k) K003446
K003446 is an FDA 510(k) premarket notification submitted by St. Jude Medical Cardiovascular Group, Inc. for the device "SYMMETRY AORTIC CLIP SYSTEM". The FDA issued a decision of Substantially Equivalent on May 21, 2001. The device falls under product code NCA (Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)), a Class II device regulated under 21 CFR 878.4300.
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