CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
FDA 510(k) clearance K172455 · decided 2017-10-25
Clearance details
- K-number
- K172455
- Device name
- CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2017-08-14
- Decision date
- 2017-10-25
- Days to decision
- 72 days
- Clearance type
- Special
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Volcano CORE M2 Vascular System, Part # 400-0100.17, Rx Only. Used for the qualita recall (Z-1891-2018) | Volcano Corporation | 2018-05-17 |