The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Hi-torque Steelcore Bare Guide Wire.
| Device ID | K200144 |
| 510k Number | K200144 |
| Device Name: | HI-TORQUE Steelcore Bare Guide Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Shilpa Satishchandra |
| Correspondent | Shilpa Satishchandra Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-01-22 |
| Decision Date | 2020-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 28717648239322 | K200144 | 000 |