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Parker Quality & Compliance

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510(k) clearance

Tigertriever 13 Ultra Revascularization Device

FDA 510(k) source

510(k) number
K260617
Applicant
Rapid Medical Ltd.
Decision date
Aug 28, 2026
Date received
Feb 25, 2026
Decision
Substantially Equivalent
Clearance type
Traditional
Product code
NRY
Device type
Catheter, Thrombus Retriever
Device class
Class II
Regulation
21 CFR 870.1250
Advisory committee
Cardiovascular
Statement or summary
Summary
Third party
N
Location
Yokneam, IL