K982272 is an FDA 510(k) clearance for the GALEO HS 014 MODEL 117 130, GALEO S 014 MODEL 115 488, GALEAO M 014 MODEL 114156, GALEO F 014 MODEL 115 487 GALEO HF 018. 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 January 8, 1999, 193 days after receiving the submission on June 29, 1998.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K982272 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 1998 |
| Decision Date | January 08, 1999 |
| Days to Decision | 193 days |
| Submission Type | Traditional |
| 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 |