Product code SCZ— Cardiovascular
ShortCut
- Classification name
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Device class
- Class 2
- Regulation
- 21 CFR 870.1254
- Advisory panel
- Cardiovascular
- Total cleared
- 1
- First cleared
- Most recent
FDA classification 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.”
Market context for product code SCZ
FDA has cleared device under product code SCZ, all in 2024, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code SCZ
Adverse events under product code SCZ
product code SCZ- Death
- 4
- Total
- 4
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code SCZ
Data sourced from openFDA. This site is unofficial and independent of the FDA.