The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Hi-torque Winn Guide Wire Family.
| Device ID | K101648 |
| 510k Number | K101648 |
| Device Name: | HI-TORQUE WINN GUIDE WIRE FAMILY |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Laarni Ricafort |
| Correspondent | Laarni Ricafort ABBOTT VASCULAR INC. 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-11 |
| Decision Date | 2010-07-08 |
| Summary: | summary |