HI-TORQUE BALANCE
Wire, Guide, Catheter
ABBOTT VASCULAR
The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Balance.
Pre-market Notification Details
| Device ID | K152709 |
| 510k Number | K152709 |
| Device Name: | HI-TORQUE BALANCE |
| Classification | Wire, Guide, Catheter |
| Applicant | ABBOTT VASCULAR 26531 YNEZ ROAD Temecula, CA 92591 |
| Contact | Jochen Reich |
| Correspondent | Jochen Reich ABBOTT VASCULAR 26531 YNEZ ROAD Temecula, CA 92591 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-21 |
| Decision Date | 2015-10-21 |
| Summary: | summary |
Trademark Results [HI-TORQUE BALANCE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HI-TORQUE BALANCE 74623411 1945635 Live/Registered |
ABBOTT CARDIOVASCULAR SYSTEMS, INC. 1995-01-20 |
 HI-TORQUE BALANCE 74276838 not registered Dead/Abandoned |
Advanced Cardiovascular Systems, Inc. 1992-05-18 |
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