Data / Medical devices / Intracardiac Patch Or Pledget, Biologically Derived / United States
FDA-registered makers of Intracardiac Patch Or Pledget, Biologically Derived in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ). 8 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Intracardiac Patch Or Pledget, Biologically Derived
- Product code
- PSQ
- Country
- United States
Makers of Intracardiac Patch Or Pledget, Biologically Derived in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Artivion, Inc. | Kennesaw, GA, United States | Complaint file establishment, Manufacturer | 2 | February 14, 2019 | 0 | 0 | 0 | api.fda.gov |
| SYNOVIS LIFE TECHNOLOGIES, INC. (A Subsidiary of Baxter International Inc.) | Saint Paul, MN, United States | Manufacturer | 2 | October 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Acell, Inc. | Columbia, MD, United States | Manufacturer | 1 | November 22, 2019 | 0 | 0 | 0 | api.fda.gov |
| Anteris Technologies Corporation | Eagan, MN, United States | Specification developer | 1 | April 3, 2020 | 0 | 0 | 0 | api.fda.gov |
| Becton, Dickinson And Company | Irvine, CA, United States | Specification developer | 1 | November 17, 2017 | 0 | 0 | 0 | api.fda.gov |
| Helios Cardio Inc. | Natick, MA, United States | Specification developer | 1 | December 21, 2021 | 0 | 0 | 0 | api.fda.gov |
| Lemaitre Vascular, Inc. | Burlington, MA, United States | Manufacturer | 1 | February 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| LeMaitre Vascular Inc. | Billerica, MA, United States | Manufacturer | 1 | February 13, 2020 | 0 | 0 | 0 | api.fda.gov |
| Cook Biotech, Inc. | West Lafayette, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lyophilization Services Of New England, Inc. | Manchester, NH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 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.