FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JETi AIO Peripheral Thrombectomy System
K Number: K213565
·
Decision Feb 1, 2022
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
9
Review Days
84
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Basic Information
- Device Name
- JETi AIO Peripheral Thrombectomy System
- K Number
- K213565
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Walk Vascular, LLC
- Date Received
- November 9, 2021
- Decision Date
- February 1, 2022
- Product Code
- QEZ
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Walk Vascular, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K201998 | JETi AIO Peripheral Thrombectomy System | Nov 17, 2020 | Substantially Equivalent |
| K192439 | JETi Peripheral Thrombectomy System | Dec 9, 2019 | Substantially Equivalent |
| K183403 | JETi 88 Peripheral Thrombectomy System | Apr 17, 2019 | Substantially Equivalent |
| K172000 | ClearLumen II Peripheral Thrombectomy System | Oct 24, 2017 | Substantially Equivalent |
| K163051 | ClearLumen II Peripheral Thrombectomy System | Feb 21, 2017 | Substantially Equivalent |
| K161786 | ClearLumen II Thrombectomy System | Oct 18, 2016 | Unknown |
| K140296 | CLEARLUMEN THROMBECTOMY SYSTEM | Dec 2, 2014 | Unknown |
| K120508 | CLEARLUMEN THROMBECTOMY SYSTEM | Nov 7, 2012 | Substantially Equivalent |