Data / Medical devices / United States / Peca Labs, Inc.
Peca Labs, Inc.: FDA-registered device maker in Pittsburgh, PA, United States, 5 510(k) clearances
Peca Labs, Inc. is registered with the FDA (registration 3013718163) in Pittsburgh, PA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 17, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013718163
- Address
- 4424 Penn Avenue Suite 201, Pittsburgh, PA, United States, 15224
- Owner or operator
- PECA Labs, Inc. (10055472)
- Roles
- Manufacturer, Manufacturer for export
- First device listed
- July 28, 2017
- Registered through
- 2026
- Brand names listed
- exGraft, exGraft E20P, exGraft Peripheral, exGraft and exGraft Carbon ePTFE Vascular Grafts, exGraft ePTFE Vascular Graft
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | 2 | Manufacturer, Manufacturer for export | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of Less Then 6mm Diameter | DYF | 2 | 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 |
|---|---|---|---|---|---|---|
| January 17, 2024 | K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | DSY | Substantially Equivalent | Peca Labs, Inc. | accessdata.fda.gov |
| August 4, 2022 | K221628 | exGraft, exGraft Carbon | DSY | Substantially Equivalent | Peca Labs | accessdata.fda.gov |
| December 11, 2020 | K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | DSY | Substantially Equivalent | Peca Labs | accessdata.fda.gov |
| April 22, 2019 | K183613 | exGraft, exGraft Carbon | DSY | Substantially Equivalent | Peca Labs | accessdata.fda.gov |
| August 21, 2018 | K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | DSY | Substantially Equivalent | Peca Labs | accessdata.fda.gov |
Compare with other makers
- All makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- All makers of Prosthesis, Vascular Graft, Of Less Then 6mm Diameter
Updated January 17, 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.