The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Hi-torque Progress Guide Wire Family.
| Device ID | K091825 |
| 510k Number | K091825 |
| Device Name: | HI-TORQUE PROGRESS GUIDE WIRE FAMILY |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR INC. 41888 MOTOR CAR PARKWAY Temecula, CA 92591 |
| Contact | Michele Walz |
| Correspondent | Michele Walz ABBOTT VASCULAR INC. 41888 MOTOR CAR PARKWAY Temecula, CA 92591 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-19 |
| Decision Date | 2009-09-25 |
| Summary: | summary |