Peca Labs, Inc.
Pittsburgh, PA, US
PECA LABS, INC. appears in FDA device records in Pittsburgh, PA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Peca Labs, Inc. between 2018 and 2024. The busiest year on record is 2018, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K233783 | exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts | DSY | Substantially Equivalent | |
| K221628 | exGraft, exGraft Carbon | DSY | Substantially Equivalent | |
| K202471 | exGraft ePTFE Vascular Graft, exGraft Carbon ePTFE Vascular Graft | DSY | Substantially Equivalent | |
| K183613 | exGraft, exGraft Carbon | DSY | Substantially Equivalent | |
| K180957 | exGraft, exGraft Carbon ePTFE Vascular Grafts | DSY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013718163 | 3013718163 | PECA LABS, INC. | 4424 Penn Avenue, Pittsburgh, PA 15224 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain