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# FDA Clears BioCardia’s Avance Steerable Introducer
- URL: https://www.fdaweb.com/fda-clears-biocardias-avance-steerable-introducer/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:20.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5144066

FDA has cleared a BioCardia 510(k) for the Avance steerable introducer, which is designed for introducing various cardiovascular catheters into the heart, including via the left side of the heart through the interatrial septum. The company says the device is “virtually whipless around curves due to their helically arranged pull-wires, enabling greater predictability, stability and control during procedures.” They are also bidirectional to allow better control within the heart. Additionally, the device offers a rotating hemostasis side port, which helps reduce physician frustration with tangled fluid lines during a procedure, it says.