Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter— 510(k) K143041
Substantially EquivalentNatec Medical , Ltd.
FDA 510(k) clearance K143041 for Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter, Substantially Equivalent on 2015-06-04. Applicant: Natec Medical , Ltd..
Clearance details
- Applicant
- Natec Medical , Ltd.
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Reduit, MU
Adverse events under product code LIT
product code LIT- Death
- 27
- Injury
- 1,256
- Malfunction
- 12,127
- Total
- 13,410
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.