510(k) K190753
K190753 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. (Formerly D.B.A. Ev3, Inc. Covidien, LLC.) for the device "EverCrossTM 0.035 OTW PTA Dilatation Catheter". The FDA issued a decision of Substantially Equivalent on Apr 23, 2019. The device falls under product code LIT (Catheter, Angioplasty, Peripheral, Transluminal), a Class II device regulated under 21 CFR 870.1250.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 23, 2019
- Date Received
- Mar 25, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Angioplasty, Peripheral, Transluminal
- Device Class
- Class II
- Regulation Number
- 870.1250
- Review Panel
- CV
- Submission Type
- 510(k)