The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Steerable Guide Catheter.
| Device ID | K172394 |
| 510k Number | K172394 |
| Device Name: | Steerable Guide Catheter |
| Classification | Catheter, Steerable |
| Applicant | Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Contact | Makena Mc Gowan |
| Correspondent | Makena Mc Gowan Abbott Vascular 3200 Lakeside Drive Santa Clara, CA 95054 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-08 |
| Decision Date | 2017-09-06 |
| Summary: | summary |