K172394 is an FDA 510(k) clearance for the Steerable Guide Catheter. This device is classified as a Catheter, Steerable (Class II - Special Controls, product code DRA).
Submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on September 6, 2017, 29 days after receiving the submission on August 8, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1280.
| 510(k) Number | K172394 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 08, 2017 |
| Decision Date | September 06, 2017 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRA — Catheter, Steerable |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1280 |