The following data is part of a premarket notification filed by Abbott Vascular with the FDA for Steerable Guide Catheter.
| Device ID | K112239 |
| 510k Number | K112239 |
| Device Name: | STEERABLE GUIDE CATHETER |
| Classification | Catheter, Steerable |
| Applicant | Abbott Vascular 4045 CAMPBELL AVE Menlo Park, CA 94025 |
| Contact | Cynthia Morrow |
| Correspondent | Cynthia Morrow Abbott Vascular 4045 CAMPBELL AVE Menlo Park, CA 94025 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-08-04 |
| Decision Date | 2011-08-31 |
| Summary: | summary |