FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
K Number: K222694
·
Decision Apr 27, 2023
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
35
Applicant Total
85
Review Days
233
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Basic Information
- Device Name
- EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190)
- K Number
- K222694
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroVention, Inc.
- Date Received
- September 6, 2022
- Decision Date
- April 27, 2023
- Product Code
- NTE
- 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 |
|---|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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