K182844 is an FDA 510(k) clearance for the ASAHI SASUKE. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Asahi Intecc Co., Ltd. (Seto, JP). The FDA issued a Cleared decision on June 22, 2019, 256 days after receiving the submission on October 9, 2018.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K182844 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 2018 |
| Decision Date | June 22, 2019 |
| Days to Decision | 256 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 |