FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
K Number: K202218
·
Decision Oct 2, 2020
Classifications
1
FEI Numbers
71
Registration Numbers
71
Same Product Code
140
Applicant Total
231
Review Days
57
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Basic Information
- Device Name
- ZelanteDVT THrombectomy System, ZelanteDVT ClotHunter Helical Rotation Device
- K Number
- K202218
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5150
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Boston Scientific Corporation
- Date Received
- August 6, 2020
- Decision Date
- October 2, 2020
- 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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