S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
FDA 510(k) clearance K082229 · decided 2008-10-08
Clearance details
- K-number
- K082229
- Device name
- S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM
- Applicant
- Volcano Corporation
- Decision
- Substantially Equivalent
- Date received
- 2008-08-07
- Decision date
- 2008-10-08
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- IYO
- Device class
- 2
- Regulation number
- 892.1560
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Rancho Cordova,, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ComboMap Intravascular Flow and Pressure System; Product/Part number: Combo Map - 802745-0 recall (Z-2045-2015) | Volcano Corp | 2015-07-08 |
| Volcano brand Intravascular Ultrasound, Volcano s5/s5i Family Software Version 3.2.1 or 3. recall (Z-2345-2012) | Volcano Corporation | 2012-09-10 |
| Volcano s5/s5i imaging system Family Software version 3.2, Part Numbers 435-0602.01 to 05, recall (Z-0168-2011) | Volcano Corporation | 2010-11-01 |