FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Artix BG
K Number: K223000
·
Decision Jan 11, 2023
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
26
Review Days
105
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Basic Information
- Device Name
- Artix BG
- K Number
- K223000
- 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
- Date Received
- September 28, 2022
- Decision Date
- January 11, 2023
- 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
| 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 |
| 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 |
| K210195 | Triever Catheters | Feb 24, 2021 | Substantially Equivalent |