510(k) K213166

Device
Thrombuster II Aspiration Catheter
Applicant
Kaneka Medical America, LLC
510(k) number
K213166
Product code
QEZ
Decision
Substantially Equivalent (SESE)
Decision date
2021-10-26
Date received
2021-09-28
Regulation
870.5150
Classification name
Aspiration Thrombectomy Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Audra Bogucki
Address
623 Fifth Ave. New York NY US 10022 10022

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K211081AlphaVac Multipurpose Mechanical Aspiration (MMA) SystemAngioDynamics, Inc.2021-06-04
K201998JETi AIO Peripheral Thrombectomy SystemWalk Vascular, LLC2020-11-17