510(k) K213593
K213593 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD". The FDA issued a decision of Substantially Equivalent on January 14, 2022. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 14, 2022
- Date Received
- November 12, 2021
- 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.