510(k) DEN240017
- Device
- ShortCut
- Applicant
- Pi-Cardia, Ltd.
- 510(k) number
- DEN240017
- Product code
- SCZ
- Decision
- Unknown (DENG)
- Decision date
- 2024-09-27
- Date received
- 2024-04-17
- Regulation
- 870.1254
- Classification name
- Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Related Records
Applicant Contact
- Contact
- Hadas Givon
- Address
- 5 David Fikes St. Rehovot IL 7632805 7632805
FDA Registration Numbers
- 3008729892
- 3033307537
- 3030471525
Source Documents
510(k) summary PDF not indicated by FDA
Related GUDID Devices
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290020101242 | ShortCut | PI-CARDIA LTD | 2024-12-05 |