K170664 is an FDA 510(k) clearance for the Odyssey Micro Catheter. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Heraeus Medical Components, LLC (Plymouth, US). The FDA issued a Cleared decision on November 9, 2017, 248 days after receiving the submission on March 6, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K170664 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2017 |
| Decision Date | November 09, 2017 |
| Days to Decision | 248 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |