510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K221528Substantially Equivalent

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

Edwards Lifesciences LLC, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K221528 is the FDA 510(k) clearance record for Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter, a class II device, cleared for Edwards Lifesciences, LLC on under FDA product code DXF (Catheter, Septostomy). FDA records list 165 510(k) clearances for Edwards Lifesciences, LLC, from to . As of , FDA records show no recalls naming K221528.

Clearance record

Decision date
Received
(88 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
Edwards Lifesciences, LLC 1 Edwards Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DXF

Trailing 12 months
3 clearances under product code DXF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260