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FDA 510(k)

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter

K-Number: K221528 · 2022-08-22

ApplicantEdwards Lifesciences, LLC
Decision Date2022-08-22
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2022-08-22 under approval number K221528. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter?

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter is a medical device that received FDA 510(k) clearance on 2022-08-22. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K221528.

When was Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter approved by the FDA?

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter received FDA 510(k) clearance on 2022-08-22, under approval number K221528.

What company makes Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter?

Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter?

The FDA product code for Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter is DXF.

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Related Devices (Code: DXF)

K182399Park Blade Septostomy CatheterCook Incorporated K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. K242076VersaCross™ RF WireBaylis Medical Company K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)Circa Scientific, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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