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Percutaneous Catheter For Electrosurgical Cutting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

FDA product code SGO · 1 cleared devices

Class 2 Cardiovascular
Regulation
21 CFR 870.1254
Review panel
CV
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-11-13 – 2025-11-13

The device is intended for electrosurgically splitting valve leaflets to facilitate a planned valvular procedure

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