VISIONS PV .035 DITITAL IVUS CATHETER
FDA 510(k) clearance K121273 · decided 2012-09-10
Clearance details
- K-number
- K121273
- Device name
- VISIONS PV .035 DITITAL IVUS CATHETER
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2012-04-27
- Decision date
- 2012-09-10
- Days to decision
- 136 days
- Clearance type
- Abbreviated
- Product code
- OBJ
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Volcano PV .035 Catheter: Part number: 88901; Product Usage: The Volcano PV .035 is indica recall (Z-1844-2015) | Volcano Corporation | 2015-06-25 |