Submission Details
| 510(k) Number | K150442 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 20, 2015 |
| Decision Date | September 04, 2015 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Volcano Visions PV .018 Digital IVUS Catheter
Sep 2015
Decision
196d
Days
Class 2
Risk
About This 510(k) Submission
K150442 is an FDA 510(k) clearance for the Volcano Visions PV .018 Digital IVUS Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Volcano Corporation (San Diego, US). The FDA issued a Cleared decision on September 4, 2015, 196 days after receiving the submission on February 20, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |
Manufacturer
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