Data / Medical devices / United States / Cardiogard Usa, Inc
Cardiogard Usa, Inc: FDA-registered device maker in Tyngsboro, MA, United States, 1 510(k) clearance
Cardiogard Usa, Inc is registered with the FDA (registration 3011427673) in Tyngsboro, MA, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 17, 2019. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3011427673
- Address
- 100 Business Park Dr. #5, Tyngsboro, MA, United States, 01879
- Owner or operator
- CardioGard USA, Inc (10048779)
- Roles
- Specification developer
- First device listed
- April 18, 2022
- Registered through
- 2026
- Brand names listed
- CardioGard Emboli Protection Cannula
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 17, 2019 | K182302 | CardioGard Emboli Protection Cannula | DWF | Substantially Equivalent | Cardiogard Medical, Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 17, 2019. 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.