FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AlphaVac MMA F1885 System (H787253020)
K Number: K240397
·
Decision Apr 1, 2024
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
85
Applicant Total
24
Review Days
52
Basic Information
- Device Name
- AlphaVac MMA F1885 System (H787253020)
- K Number
- K240397
- 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
- February 9, 2024
- Decision Date
- April 1, 2024
- 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.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K202347 | UNIFUSE Infusion System with Cooper Wire | Sep 15, 2020 | Substantially Equivalent |
| K190559 | SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports | May 22, 2020 | Substantially Equivalent |
| K190594 | AngioVac C20, AngioVac C180 | Jul 5, 2019 | Substantially Equivalent |