Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
A percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures is a single-use cardiovascular catheter system intended to mechanically split aortic valve leaflets that may obstruct coronary artery ostia during planned transcatheter valve procedures, preventing a potentially life-threatening complication. It is classified as FDA Class II (510(k) required) under regulation 870.1254 in the Cardiovascular specialty, with product code SCZ. The device is not an implant and does not support life-sustaining functions.
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Basic Information
- Product Code
- SCZ
- Device Class
- FDA class 2
- Regulation Number
- 870.1254
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| DEN240017 | ShortCut | Sep 27, 2024 | Unknown | Pi-Cardia, Ltd. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.