510(k) K201775
K201775 is an FDA 510(k) premarket notification submitted by Nuvera Medical, Inc. for the device "NuVision ICE Catheter". The FDA issued a decision of Substantially Equivalent on Mar 5, 2021. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 5, 2021
- Date Received
- Jun 29, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
- 510(k)
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.