K033320 is an FDA 510(k) clearance for the SCOUT PRO. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on November 19, 2003, 35 days after receiving the submission on October 15, 2003.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K033320 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 15, 2003 |
| Decision Date | November 19, 2003 |
| Days to Decision | 35 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |