EverCrossTM 0.035 OTW PTA Dilatation Catheter— 510(k) K190753
Substantially EquivalentMedtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
FDA 510(k) clearance K190753 for EverCrossTM 0.035 OTW PTA Dilatation Catheter, Substantially Equivalent on 2019-04-23. Applicant: Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.).
Clearance details
- Applicant
- Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
- Product code
- Code LIT
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Plymouth, MN, US
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.