LiPPS Analyzer, LiPPS Wire Pressure Guide Wire— 510(k) K201720
Substantially EquivalentBeijing Bywave Sensing Medical Technology Co., Ltd.
FDA 510(k) clearance K201720 for LiPPS Analyzer, LiPPS Wire Pressure Guide Wire, Substantially Equivalent on 2021-02-18. Applicant: Beijing Bywave Sensing Medical Technology Co., Ltd..
Clearance details
- Applicant
- Beijing Bywave Sensing Medical Technology Co., Ltd.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Beijing, CN
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.