FDA.report

510(k) K232312

Device
GORE® PROPATEN® Vascular Graft
Applicant
W. L. Gore & Associates, Inc.
510(k) number
K232312
Product code
DSY
Decision
Substantially Equivalent (SESE)
Decision date
2024-01-09
Date received
2023-08-02
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
N

Related Records

Applicant Contact

Contact
Sarah Pastrnak
Address
1505 N Fourth St. Flagstaff AZ US 86004 86004

FDA Registration Numbers

Source Documents

510(k) summary PDF

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