K101497 is an FDA 510(k) clearance for the DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY. This device is classified as a Introducer, Catheter (Class II - Special Controls, product code DYB).
Submitted by Oscor, Inc. (Palm Harbor, US). The FDA issued a Cleared decision on October 20, 2010, 141 days after receiving the submission on June 1, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340.
| 510(k) Number | K101497 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2010 |
| Decision Date | October 20, 2010 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYB - Introducer, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |