FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFIA Plus Aspiration Catheter
K Number: K173200
·
Decision Jun 11, 2018
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
85
Review Days
252
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Basic Information
- Device Name
- SOFIA Plus Aspiration Catheter
- K Number
- K173200
- 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
- October 2, 2017
- Decision Date
- June 11, 2018
- Product Code
- NRY
- 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 |
|---|---|---|---|
| NRY | Catheter, Thrombus Retriever | FDA class 2 | Cardiovascular |
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