K001736 is an FDA 510(k) clearance for the GALEO HYDRO AND GALEO HYDRO J-TIP. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on August 2, 2000, 56 days after receiving the submission on June 7, 2000.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K001736 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 07, 2000 |
| Decision Date | August 02, 2000 |
| Days to Decision | 56 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |