K093431 is an FDA 510(k) clearance for the CLEARWAY OTW MODEL 85912. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on April 20, 2010, 167 days after receiving the submission on November 4, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K093431 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2009 |
| Decision Date | April 20, 2010 |
| Days to Decision | 167 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |