The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Perclose Vascular Suture Delivery Device.
| Device ID | K001703 |
| 510k Number | K001703 |
| Device Name: | PERCLOSE VASCULAR SUTURE DELIVERY DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polypropylene |
| Applicant | ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Contact | Denise C Sungleton |
| Correspondent | Denise C Sungleton ABBOTT VASCULAR INC. 400 SAGINAW DR. Redwood City, CA 94063 |
| Product Code | GAW |
| Subsequent Product Code | GAB |
| Subsequent Product Code | HCF |
| CFR Regulation Number | 878.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-05 |
| Decision Date | 2000-10-03 |