IntraClude Intra-Aortic Occlusion Device
FDA 510(k) clearance K163693 · decided 2017-01-26
Clearance details
- K-number
- K163693
- Device name
- IntraClude Intra-Aortic Occlusion Device
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2016-12-28
- Decision date
- 2017-01-26
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), recall (Z-1705-2019) | Edwards Lifesciences, LLC | 2019-06-11 |