SCZClass II
Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Cardiovascular · 21 CFR 870.1254
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.
MDR events16All time
Recalls0All time
Registered firms3Currently listed
510(k) clearances1All time
Recent MDR events
16 adverse event reports on file
- SHORTCUTJul 15, 2026MalfunctionPi-cardia Ltd.3030471525-2026-00009
- SHORTCUTJun 29, 2026InjuryPi-cardia Ltd.3030471525-2026-00008
- SHORTCUTJun 14, 2026DeathPi-cardia Ltd.3030471525-2026-00007
- SHORTCUTMay 26, 2026DeathPi-cardia Ltd.3030471525-2026-00006
- SHORTCUTMay 19, 2026InjuryPi-cardia Ltd.3030471525-2026-00005
- SHORTCUTMay 18, 2026InjuryPi-cardia Ltd.3030471525-2026-00004
- SHORTCUTMar 12, 2026DeathPi-cardia Ltd.3030471525-2026-00003
- SHORTCUTFeb 3, 2026InjuryPi-cardia Ltd.3030471525-2026-00002
- SHORTCUTJan 28, 2026InjuryPi-cardia Ltd3030471525-2026-00001
- SHORTCUTDec 25, 2025DeathPi-cardia Ltd3030471525-2025-00006
Event type breakdown
Injury9
Death6
Malfunction1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
3 firms currently registered for this product code
510(k) clearances
1 clearances for this product code