510(k) K223077
K223077 is an FDA 510(k) premarket notification submitted by Irvine Biomedical, A St. Jude Medical Company for the device "ViewFlex Xtra ICE Catheter". The FDA issued a decision of Substantially Equivalent on December 7, 2022. 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
- December 7, 2022
- Date Received
- September 30, 2022
- Clearance Type
- Special
- 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
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.