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510(k) K221528

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter by Edwards Lifesciences, LLC — Product Code DXF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 22, 2022
Date Received
May 26, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Septostomy
Device Class
Class II
Regulation Number
870.5175
Review Panel
CV
Submission Type

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  • K240900 — HOTWIRE™ RF Guidewire (May 1, 2024)
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