FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ENROUTE® Transcarotid Neuroprotection System
K Number: K230402
·
Decision Apr 11, 2023
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
35
Applicant Total
1
Review Days
55
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Basic Information
- Device Name
- ENROUTE® Transcarotid Neuroprotection System
- K Number
- K230402
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Silk Road Medical
- Date Received
- February 15, 2023
- Decision Date
- April 11, 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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