FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FlowTriever2 Catheter
K Number: K250088
·
Decision Mar 13, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
30
Review Days
58
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
- FlowTriever2 Catheter
- K Number
- K250088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inari Medical, Inc.
- Date Received
- January 14, 2025
- Decision Date
- March 13, 2025
- 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, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K252508 | Intri26 Introducer Sheath | Dec 17, 2025 | Substantially Equivalent |
| K250421 | InThrill Thrombectomy System | May 12, 2025 | Substantially Equivalent |
| K241894 | Artix MT; Artix Thin-Walled Thrombectomy Sheath | Oct 15, 2024 | Substantially Equivalent |
| K242557 | ClotTriever XL Catheter (41-102) | Sep 27, 2024 | Substantially Equivalent |
| K233069 | Removal System Large Bore 60 cc Syringe | Mar 26, 2024 | Substantially Equivalent |
| K234034 | VenaCore Thrombectomy Catheter (46-101) | Feb 9, 2024 | Substantially Equivalent |
| K233815 | ClotTriever Sheath | Dec 18, 2023 | Substantially Equivalent |
| K233646 | Intri24 Introducer Sheath (52-101) | Dec 12, 2023 | Substantially Equivalent |
| K231108 | Talon Transseptal Sheath | Sep 27, 2023 | Substantially Equivalent |
| K231848 | Triever20 Curve (21-201) | Jul 21, 2023 | Substantially Equivalent |