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FDA-cleared K243884

TAVIPILOT

Caranx Medical

Authorized purpose: TAVIPILOT detects, tracks, and marks the non-coronary cusp and prosthetic valve on live fluoroscopy during specified adult femoral TAVR or TAVI procedures under physician control.

Modality
Fluoroscopy/Angiography
Anatomy
Heart/Cardiovascular
Decision
2025-07-07