510(k) K202800
K202800 is an FDA 510(k) premarket notification submitted by Medtronic Vascular,Inc(Formerly D.B.A Ev3 Inc.,Covidien, LLC) for the device "Pacific Plus PTA Catheter". The FDA issued a decision of Substantially Equivalent on Nov 18, 2020. 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
- Nov 18, 2020
- Date Received
- Sep 23, 2020
- Clearance Type
- Traditional
- 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)