ULTRASKIN HYDROPHILIC GUIDE WIRE— 510(k) K141707
Substantially EquivalentLepu Medical Technology (Beijing) Co., Ltd.
FDA 510(k) clearance K141707 for ULTRASKIN HYDROPHILIC GUIDE WIRE, Substantially Equivalent on 2015-01-21. Applicant: Lepu Medical Technology (Beijing) Co., Ltd..
Clearance details
- Applicant
- Lepu Medical Technology (Beijing) Co., Ltd.
- Product code
- Code DQX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South Euclid, OH, US
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.