REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
FDA 510(k) K160583 · Volcano Corporation
510(k) numberK160583
Submission
- Device name
- REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- March 1, 2016
- Decision date
- October 26, 2016
- 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 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip cleared by the FDA?
REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip (K160583) received a 510(k) decision of Substantially Equivalent on October 26, 2016, 239 days after the submission was received.
What is the product code of K160583?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.