REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
FDA 510(k) clearance K160583 · decided 2016-10-26
Clearance details
- K-number
- K160583
- Device name
- REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2016-03-01
- Decision date
- 2016-10-26
- Days to decision
- 239 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289 recall (Z-1775-2017) | Volcano Corporation | 2017-04-10 |
| Refinity Short Tip Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 40 recall (Z-1776-2017) | Volcano Corporation | 2017-04-10 |