Opticross 40 MHZ Coronary Imaging Catheter
FDA 510(k) K123621 · Boston Scientific Corp
510(k) numberK123621
Submission
- Device name
- Opticross 40 MHZ Coronary Imaging Catheter
- Applicant
- Boston Scientific Corp
Fremont, CA, US - Received
- November 23, 2012
- Decision date
- April 15, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 40 MHZ Coronary Imaging Catheter cleared by the FDA?
Opticross 40 MHZ Coronary Imaging Catheter (K123621) received a 510(k) decision of Substantially Equivalent on April 15, 2013, 143 days after the submission was received.
What is the product code of K123621?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.