FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Protrieve Sheath
K Number: K253323
·
Decision Oct 29, 2025
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
26
Review Days
29
Basic Information
- Device Name
- Protrieve Sheath
- K Number
- K253323
- 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
- September 30, 2025
- Decision Date
- October 29, 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 |
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|---|---|---|---|
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