FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

BioCardia’s Steerable Catheter Introducers Earn FDA Clearance

May 13, 2019
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The FDA has given BioCardia’s Avance steerable catheter introducers 510(k) marketing clearance. The product family is designed to introduce catheters into the heart.

The devices place catheters used for diagnosing and treating heart conditions via the left side of the heart by way of the interatrial septum.

The introducers include spiral-arranged pull-wires that offer better control and stability for transseptal procedures. They also are bidirectional and allow for catheter conformance to the patient’s anatomy.

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