K192599 is an FDA 510(k) clearance for the ASAHI PTCA Guide Wire ASAHI Gaia Next. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on January 2, 2020, 104 days after receiving the submission on September 20, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K192599 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 20, 2019 |
| Decision Date | January 02, 2020 |
| Days to Decision | 104 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 |