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Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures

Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.

Global Registration Data
Multi-Country Intelligence
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Cardiovascular Medical Device Type
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Regulatory Classifications

US Regulatory Classifications

SCZ

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Class 2

21 CFR 870.1254

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Cardiovascular

Device Characteristics

No

No

No

Not Eligible

Definition

The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures.