FDA.report

510(k) K233783

Device
exGraft ePTFE Vascular Grafts, exGraft Carbon ePTFE Vascular Grafts
Applicant
Peca Labs, Inc.
510(k) number
K233783
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-17
Date received
2023-11-27
Regulation
870.3450
Classification name
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Doug Bernstein
Address
4424 Penn Ave. Suite 201 Pittsburgh PA US 15224 15224

FDA Registration Numbers

Source Documents

510(k) summary PDF

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