FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Viradius Neurowire
K Number: K151825
·
Decision Nov 16, 2015
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
39
Applicant Total
5
Review Days
133
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Basic Information
- Device Name
- Viradius Neurowire
- K Number
- K151825
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mivi Neuroscience, Inc.
- Date Received
- July 6, 2015
- Decision Date
- November 16, 2015
- Product Code
- MOF
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| MOF | Guide, Wire, Catheter, Neurovasculature | FDA class 2 | Cardiovascular |
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Other Clearances by Mivi Neuroscience, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K222948 | Q Distal Access Catheter | Sep 19, 2023 | Substantially Equivalent |
| K212402 | MIVI Q Distal Access Catheter | Dec 16, 2021 | Substantially Equivalent |
| K163233 | MIVI 6F 25cm Mi-EXT Extension Catheter, MIVI 5F 25cm Mi-EXT Extension Catheter, MIVI 4F 30cm Mi-EXT Extension Catheter, MIVI 3F 43cm Mi-EXT Extension Catheter | Apr 6, 2017 | Substantially Equivalent |
| K151396 | MIVI Mi-AXUS Guide Catheter | Dec 9, 2015 | Substantially Equivalent |