FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
K Number: K211013
·
Decision Apr 30, 2021
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
30
Review Days
25
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Basic Information
- Device Name
- FlowTriever Retrieval/Aspiration System, FlowTriever Catheters, Triever 16, Triever 20, Triever 20 Curve, Triever 24
- K Number
- K211013
- 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, Inc.
- Date Received
- April 5, 2021
- Decision Date
- April 30, 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 |
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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 |
| K250088 | FlowTriever2 Catheter | Mar 13, 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 |