Pacific Plus PTA Catheter— 510(k) K202800
Substantially EquivalentMedtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC)
FDA 510(k) clearance K202800 for Pacific Plus PTA Catheter, Substantially Equivalent on 2020-11-18. Applicant: Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC).
Clearance details
- Applicant
- Medtronic Vascular,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
- Traditional
- 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.