K123765 is an FDA 510(k) clearance for the GUIDEZILLA GUIDE EXTENSION CATHETER. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on March 19, 2013, 102 days after receiving the submission on December 7, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K123765 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 07, 2012 |
| Decision Date | March 19, 2013 |
| Days to Decision | 102 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 |