Cleared Traditional

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

K221528 · Edwards Lifesciences, LLC · Cardiovascular
Aug 2022
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K221528 is an FDA 510(k) clearance for the Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter, a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on August 22, 2022, 88 days after receiving the submission on May 26, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K221528 FDA.gov
FDA Decision Cleared SESE
Date Received May 26, 2022
Decision Date August 22, 2022
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

Similar Devices — DXF Catheter, Septostomy

All 19
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
K253799 · Pressure Products Medical Device Manufacturing, LLC · Mar 2026
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
K260292 · Atraverse Medical · Feb 2026
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
K252419 · Atraverse Medical, Inc. · Aug 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007 · Circa Scientific, Inc. · May 2025
Cross Wise? Multi-Use RF Adapter Cable
K243193 · Circa Scientific, Inc. · Nov 2024
VersaCross? RF Wire
K242076 · Baylis Medical Company · Nov 2024