NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE— 510(k) K140136
Substantially EquivalentNipro Medical Corporation
FDA 510(k) clearance K140136 for NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE, Substantially Equivalent on 2014-02-14. Applicant: Nipro Medical Corporation.
Clearance details
- Applicant
- Nipro Medical Corporation
- Product code
- Code FOZ
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Miami, FL, US
Adverse events under product code FOZ
product code FOZ- Death
- 38
- Injury
- 2,290
- Malfunction
- 25,858
- Other
- 11
- Total
- 28,197
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.