510(k) K213565

Device
JETi AIO Peripheral Thrombectomy System
Applicant
Walk Vascular, LLC
510(k) number
K213565
Product code
QEZ
Decision
Substantially Equivalent (SESE)
Decision date
2022-02-01
Date received
2021-11-09
Regulation
870.5150
Classification name
Aspiration Thrombectomy Catheter
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Namratha Manthani
Address
17171 Daimler St. Irvine CA US 92618 92618

FDA Registration Numbers

Source Documents

510(k) summary PDF

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