FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NeVasc Aspiration System
K Number: K251006
·
Decision Nov 10, 2025
Classifications
1
FEI Numbers
59
Registration Numbers
59
Same Product Code
108
Applicant Total
4
Review Days
223
Basic Information
- Device Name
- NeVasc Aspiration System
- K Number
- K251006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Vesalio, Inc.
- Date Received
- April 1, 2025
- Decision Date
- November 10, 2025
- 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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