Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter— 510(k) K221528
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K221528 for Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter, Substantially Equivalent on 2022-08-22. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DXF
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DXF
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- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
More clearances from Edwards Lifesciences, LLC
view allAdverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.