FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SpeedLyser Infusion Catheter Kit
K Number: K170258
·
Decision Feb 21, 2017
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
68
Applicant Total
24
Review Days
25
Basic Information
- Device Name
- SpeedLyser Infusion Catheter Kit
- K Number
- K170258
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- AngioDynamics, Inc.
- Date Received
- January 27, 2017
- Decision Date
- February 21, 2017
- Product Code
- QEY
- 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 |
|---|---|---|---|
| QEY | Mechanical Thrombolysis Catheter | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QEY), ordered by most recent decision date.
Versus Catheter (VS110-8B)
FDA 510(k)
FDA Class 2
·Cardiovascular
BASHIR .035 Endovascular Catheter, BASHIR S-B .035 Endovascular Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BASHIR Endovascular Catheter Ref. No. 7201, BASHIR S-B Endovascular Catheter, Ref. No. 7101
FDA 510(k)
FDA Class 2
·Cardiovascular
EKOS+ Endovascular Device
FDA 510(k)
FDA Class 2
·Cardiovascular
EkoSonic Endovascular Device, EKOS+ Endovascular Device
FDA 510(k)
FDA Class 2
·Cardiovascular
EkoSonic Endovascular Device
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by AngioDynamics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| 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 |