FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Triever Catheters
K Number: K210195
·
Decision Feb 24, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
26
Review Days
30
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Triever Catheters
- K Number
- K210195
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inari Medical
- Date Received
- January 25, 2021
- Decision Date
- February 24, 2021
- Product Code
- QEW
- 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 |
|---|---|---|---|
| QEW | Peripheral Mechanical Thrombectomy With Aspiration | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEW), ordered by most recent decision date.
INDIGO® Aspiration System INDIGO Link
FDA 510(k)
FDA Class 2
·Cardiovascular
CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
FDA 510(k)
FDA Class 2
·Cardiovascular
INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
FDA 510(k)
FDA Class 2
·Cardiovascular
RoVo Mechanical Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Sangria Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Helo Thrombectomy System
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Inari Medical
| K Number | Device Name | ||
|---|---|---|---|
| K253323 | Protrieve Sheath | Oct 29, 2025 | Substantially Equivalent |
| K230912 | Artix BG | May 2, 2023 | Substantially Equivalent |
| K223419 | Triever16 Curve | Mar 23, 2023 | Substantially Equivalent |
| K223436 | Artix AX | Mar 2, 2023 | Substantially Equivalent |
| K223000 | Artix BG | Jan 11, 2023 | Substantially Equivalent |
| K220887 | Mini-ClotTriever Thrombectomy System | Aug 4, 2022 | Substantially Equivalent |
| K221846 | Artix Ballon Guiding Sheath | Jul 11, 2022 | Substantially Equivalent |
| K213402 | Triever24, Triever20 | May 23, 2022 | Substantially Equivalent |
| K220600 | Artix Thrombectomy Device | Mar 25, 2022 | Substantially Equivalent |
| K210176 | FlowSaver Blood Filter | Jul 22, 2021 | Substantially Equivalent |