EverCrossTM 0.035 OTW PTA Dilatation Catheter
FDA 510(k) clearance K190753 · decided 2019-04-23
Clearance details
- K-number
- K190753
- Device name
- EverCrossTM 0.035 OTW PTA Dilatation Catheter
- Applicant
- Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.)
- Decision
- Substantially Equivalent
- Date received
- 2019-03-25
- Decision date
- 2019-04-23
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- LIT
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.