FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FlowSaver Blood Return System
K Number: K221483
·
Decision Feb 17, 2023
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
30
Review Days
270
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Basic Information
- Device Name
- FlowSaver Blood Return System
- K Number
- K221483
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Inari Medical, Inc.
- Date Received
- May 23, 2022
- Decision Date
- February 17, 2023
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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| 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 |