The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Starclose Introducer Set Model- 1002.
| Device ID | K060902 |
| 510k Number | K060902 |
| Device Name: | STARCLOSE INTRODUCER SET MODEL- 1002 |
| Classification | Introducer, Catheter |
| Applicant | ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Contact | Kim Smith -servance |
| Correspondent | Kim Smith -servance ABBOTT VASCULAR INC. 400 Saginaw Drive Redwood City, CA 94063 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-03 |
| Decision Date | 2006-07-07 |
| Summary: | summary |