K201720 is an FDA 510(k) clearance for the LiPPS Analyzer, LiPPS Wire Pressure Guide Wire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Beijing Bywave Sensing Medical Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on February 18, 2021, 240 days after receiving the submission on June 23, 2020.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K201720 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 23, 2020 |
| Decision Date | February 18, 2021 |
| Days to Decision | 240 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 |