Data / Medical devices / Israel / Pi-Cardia Ltd
Pi-Cardia Ltd: FDA-registered device maker in Rehovot Central, Israel, 1 510(k) clearance
Pi-Cardia Ltd is registered with the FDA (registration 3030471525) in Rehovot Central, Israel. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2024. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3030471525
- Address
- David Fikes 5, Rehovot Central, Israel, 7632805
- Owner or operator
- Pi-Cardia LtD (10091623)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- October 21, 2024
- Registered through
- 2027
- Brand names listed
- ShortCut
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures | SCZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 27, 2024 | DEN240017 | ShortCut | SCZ | Unknown | Pi-Cardia, Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 6, 2026 | 99664 | Class II | Ongoing | Pi-Cardia Inc. ShortCut REF: Z-A-20.003-US | Transfemoral catheter, positing arm may detached due to weld issue. | accessdata.fda.gov |
Updated September 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.