Visions PV .035 Digital IVUS Catheter
FDA 510(k) K153094 · Volcano Corporation
510(k) numberK153094
Submission
- Device name
- Visions PV .035 Digital IVUS Catheter
- Applicant
- Volcano Corporation
San Diego, CA, US - Received
- October 26, 2015
- Decision date
- December 31, 2015
- 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 Visions PV .035 Digital IVUS Catheter cleared by the FDA?
Visions PV .035 Digital IVUS Catheter (K153094) received a 510(k) decision of Substantially Equivalent on December 31, 2015, 66 days after the submission was received.
What is the product code of K153094?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.