The following data is part of a premarket notification filed by St. Jude Medical Cardiovascular Group, Inc. with the FDA for Symmetry Aortic Clip System.
| Device ID | K003446 |
| 510k Number | K003446 |
| Device Name: | SYMMETRY AORTIC CLIP SYSTEM |
| Classification | Clip, Implantable, For Coronary Artery Bypass Graft (cabg) |
| Applicant | ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Contact | Robert L Sheridan |
| Correspondent | Robert L Sheridan ST. JUDE MEDICAL CARDIOVASCULAR GROUP, INC. 12300 TWINBROOK PKWY. SUITE 625 Rockville, MD 20852 |
| Product Code | NCA |
| CFR Regulation Number | 878.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-11-06 |
| Decision Date | 2001-05-21 |
| Summary: | summary |