Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
FDA 510(k) clearance K193379 · decided 2020-06-12
Clearance details
- K-number
- K193379
- Device name
- Fogarty Arterial Embolectomy Catheter, Fogarty Biliary Balloon Probe
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-12-05
- Decision date
- 2020-06-12
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- DXE
- Device class
- 2
- Regulation number
- 870.5150
- 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 |
|---|---|---|
| Fogarty Arterial Embolectomy Catheters Model Number: 120602FP 120403FP 120803FP 120404FP 1 recall (Z-0146-2023) | Edwards Lifesciences, LLC | 2022-10-28 |
| Fogarty Biliary Balloon Probes Model Number: 410235FP 410405FP 410236FP recall (Z-0147-2023) | Edwards Lifesciences, LLC | 2022-10-28 |