OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
FDA 510(k) K213593 · Boston Scientific Corporation
510(k) numberK213593
Submission
- Device name
- OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- November 12, 2021
- Decision date
- January 14, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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Questions and answers
When was OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD cleared by the FDA?
OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD (K213593) received a 510(k) decision of Substantially Equivalent on January 14, 2022, 63 days after the submission was received.
What is the product code of K213593?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.