PECA LABS, INC.

FDA Device Registration & Listing · Pittsburgh, PA, US · Registration 3013718163

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013718163
FEI Number
3013718163
Entity Name
PECA LABS, INC.
City/State/Country
Pittsburgh, PA, US
Establishment Address
4424 Penn Avenue, Suite 201, Pittsburgh, PA 15224, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PECA Labs, Inc. (Owner Number: 10055472)
Owner / Operator Contact Address
4424 Penn Avenue, Suite 201, Pittsburgh, PA 15224, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K183613
PMA Number
N/A

All Registered Proprietary Names

exGraft Peripheral exGraft E20P exGraft exGraft exGraft ePTFE Vascular Graft exGraft

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2017-07-28
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2018-11-16
DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter Cardiovascular Class 2 870.3450 2024-12-17
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2024-12-17
DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter Cardiovascular Class 2 870.3450 2019-07-31

Official Correspondent

Doug Bernstein

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PECA Labs, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K962639 Impra, Inc. IMPRA CARBOFLO EPTFE VASCULAR GRAFT 1996-10-03

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2026 W L Gore & Associates, Inc. 2
GORE ACUSEAL Vascular Graft, REF: ECH050020J, ECH050020W, ECH050050J, ECH050050W, ECH060010A, ECH060020A, ECH060020J, ECH060020W, ECH060040, ECH060040A, ECH060040W, ECH060050A, ECH060050J, ECH460045A, ECH460045J, ECH470045, ECH470045A; used with Instructions for Use.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013718163. Last updated year: 2026. Please use registration number 3013718163 when referencing this establishment in official correspondence.
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