The following data is part of a premarket notification filed by Abbott Vascular Inc. with the FDA for Hi-torque Balance Middleweight Universal.
| Device ID | K101011 |
| 510k Number | K101011 |
| Device Name: | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD Temecula, CA 92589 |
| Contact | Kay Setzer |
| Correspondent | Kay Setzer ABBOTT VASCULAR INC. 26531 YNEZ ROAD Temecula, CA 92589 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-05-24 |
| Summary: | summary |