The following data is part of a premarket notification filed by Abbott Vascular, Inc. with the FDA for Hi-torque Balance Middleweight Universal Ii Guide Wire.
| Device ID | K072460 |
| 510k Number | K072460 |
| Device Name: | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR, INC. 26531 YNEZ ROAD Temecula, CA 92590 -3731 |
| Contact | Michele Walz |
| Correspondent | Michele Walz ABBOTT VASCULAR, INC. 26531 YNEZ ROAD Temecula, CA 92590 -3731 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-31 |
| Decision Date | 2008-04-11 |
| Summary: | summary |