The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Flex-t Guide Wire, Models 1012067-01, 02, 03, 04 And 05.
| Device ID | K083738 |
| 510k Number | K083738 |
| Device Name: | HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 |
| Classification | Wire, Guide, Catheter |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Nadine Smith |
| Correspondent | Nadine Smith Abbott Vascular 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 | 2008-12-16 |
| Decision Date | 2009-03-11 |
| Summary: | summary |