The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Modification To: Abbott Vascular Suture Anastomosis Device.
| Device ID | K013683 |
| 510k Number | K013683 |
| Device Name: | MODIFICATION TO: ABBOTT VASCULAR SUTURE ANASTOMOSIS DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Patty Hevey |
| Correspondent | Patty Hevey ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Product Code | GAW |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-07 |
| Decision Date | 2001-12-06 |
| Summary: | summary |