Data / Medical devices / Intracardiac Patch Or Pledget, Biologically Derived
Intracardiac Patch Or Pledget, Biologically Derived (PSQ): 11 FDA-registered makers in 2 countries
11 establishments in 2 countries are registered with the FDA to make Intracardiac Patch Or Pledget, Biologically Derived (product code PSQ, Class 2, 21 CFR 870.3470). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 11 510(k) clearances under this code, the latest on October 19, 2022, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- PSQ
- Device class
- 2
- Regulation
- 870.3470
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 10 |
| Australia | 1 |
Makers of Intracardiac Patch Or Pledget, Biologically Derived
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| 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 Aus Operations Pty Ltd | Malaga Western Australia, Australia | Contract manufacturer, Manufacturer | 1 | April 3, 2020 | 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 October 19, 2022. 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.