FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AlphaVac Multipurpose Mechanical Aspiration System F1885
K Number: K252509
·
Decision Nov 24, 2025
Classifications
1
FEI Numbers
49
Registration Numbers
49
Same Product Code
91
Applicant Total
87
Review Days
108
Basic Information
- Device Name
- AlphaVac Multipurpose Mechanical Aspiration System F1885
- K Number
- K252509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AngioDynamics, Inc.
- Date Received
- August 8, 2025
- Decision Date
- November 24, 2025
- Product Code
- QEZ
- 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 |
|---|---|---|---|
| QEZ | Aspiration Thrombectomy Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by AngioDynamics, Inc.
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|---|---|---|---|
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| K240397 | AlphaVac MMA F1885 System (H787253020) | Apr 1, 2024 | Substantially Equivalent |
| K231945 | VenaCure EVLT NeverTouch Procedure Kits; VenaCure EVLT NeverTouch Direct Procedure Kits | Jul 20, 2023 | Substantially Equivalent |
| K223581 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Mar 27, 2023 | Substantially Equivalent |
| K221883 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Mar 7, 2023 | Substantially Equivalent |
| K213388 | AlphaVac Multipurpose Mechanical Aspiration (MMA) F1885 System | Apr 4, 2022 | Substantially Equivalent |
| K213067 | Solero Microwave Tissue Ablation (MTA) System and Accessories | Dec 3, 2021 | Substantially Equivalent |
| K212386 | AngioVac F18 85 | Sep 30, 2021 | Substantially Equivalent |
| K211081 | AlphaVac Multipurpose Mechanical Aspiration (MMA) System | Jun 4, 2021 | Substantially Equivalent |