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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

Protégé™ EverFlex™ Self-expanding Peripheral Stent System

FDA 510(k) source

510(k) number
K262913
Applicant
Medtronic, Inc.
Decision date
Sep 17, 2026
Date received
Aug 19, 2026
Decision
Substantially Equivalent
Clearance type
Special
Product code
FGE
Device type
Stents, Drains And Dilators For The Biliary Ducts
Device class
Class II
Regulation
21 CFR 876.5010
Advisory committee
Gastroenterology, Urology
Statement or summary
Summary
Third party
N
Location
Plymouth, MN, US