FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MIVI Q Distal Access Catheter
K Number: K212402
·
Decision Dec 16, 2021
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
5
Review Days
136
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Basic Information
- Device Name
- MIVI Q Distal Access Catheter
- K Number
- K212402
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Mivi Neuroscience, Inc.
- Date Received
- August 2, 2021
- Decision Date
- December 16, 2021
- Product Code
- QJP
- 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 |
|---|---|---|---|
| QJP | Catheter, Percutaneous, 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 |
| 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 |
| K151825 | Viradius Neurowire | Nov 16, 2015 | Substantially Equivalent |