Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
FDA 510(k) clearance K221528 · decided 2022-08-22
Clearance details
- K-number
- K221528
- Device name
- Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- Applicant
- Edwards Lifesciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2022-05-26
- Decision date
- 2022-08-22
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DXF
- Device class
- 2
- Regulation number
- 870.5175
- 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
No recalls on record reference this clearance.