Data / Medical devices / United States / Pi-Cardia Inc
Pi-Cardia Inc: FDA-registered device maker in Needham, MA, United States, 1 510(k) clearance
Pi-Cardia Inc is registered with the FDA (registration 3033307537) in Needham, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated September 27, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3033307537
- Address
- 75 2nd Ave Fl 3 Ste 300, Needham, MA, United States, 02494
- Owner or operator
- Pi-Cardia LtD (10091623)
- Roles
- Complaint file establishment
- 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 | 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 |
Updated September 27, 2024. 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.