K072329 is an FDA 510(k) clearance for the SCOUTPRO 8F, 7F AND SLITTER TOOL ADVANCED. 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 March 25, 2008, 218 days after receiving the submission on August 20, 2007.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K072329 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 20, 2007 |
| Decision Date | March 25, 2008 |
| Days to Decision | 218 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 |