ShortCut
- Primary DI
- 07290020101242
- Brand
- ShortCut
- Company
- PI-CARDIA LTD
- Model
- Z-A-20.003-US
- Device description
- Percutaneous catheter for cutting or splitting heart valve leaflets concomitant to transcatheter valve procedures.
- Published
- 2024-12-05
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
- OTC
- false
- Sterile
- true
- Single use
- true
Product Codes
| Code | Name |
|---|
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| SCZ | Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | Cardiovascular | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| DEN240017 | 000 | ShortCut | Pi-Cardia, Ltd. | 2024-09-27 | SCZ |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 07290020101242 | Primary | GS1 | 0 | |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | EAN-13 |
|---|
| 07290020101242 | 07290020101242 | 7290020101242 |
GMDN Terms
| Term | Definition |
|---|
| Cardiac valvuloplasty catheter | A sterile flexible tube with an inflatable balloon designed to perform plastic or restorative surgery on a cardiac valve, i.e., for the dilatation of atrioventricular, aortic, and pulmonary trunk valves. It is typically used for the percutaneous dilatation of commissural fusion in stenotic mitral valves and for annular, cuspal, and calcific nodular fractures, to improve cuspal mobility in adult calcific aortic stenosis, and for leaflet tearing in pulmonic valve stenosis. It may also be used for percutaneous balloon pericardiotomy. This is a single-use device. |
Regulatory Flags
- DUNS number
- 532731150
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- true
- Serial number
- true
- Manufacturing date on label
- false
- Expiration date on label
- true
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- false
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