ebb Complete Tamponade System
FDA 510(k) clearance K150573 · decided 2015-03-25
Clearance details
- K-number
- K150573
- Device name
- ebb Complete Tamponade System
- Applicant
- Clinical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2015-03-06
- Decision date
- 2015-03-25
- Days to decision
- 19 days
- Clearance type
- Special
- Product code
- OQY
- Device class
- 2
- Regulation number
- 884.4530
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in prov recall (Z-0123-2016) | Clinical Innovations, LLC | 2015-10-15 |