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Parker Quality & Compliance

PQC Reg Watch

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510(k) clearance

VasQ

FDA 510(k) source

510(k) number
K263598
Applicant
Laminate Medical Technologies
Decision date
Oct 29, 2026
Date received
Sep 30, 2026
Decision
Substantially Equivalent
Clearance type
Special
Product code
QVQ
Device type
Extravascular Support For An Arteriovenous Fistula For Vascular Access
Device class
Class II
Regulation
21 CFR 870.4600
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Tel Aviv, IL