FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO: SMITHWICK CAROTID SHUNT
K Number: K061484
·
Decision Dec 7, 2006
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
3
Review Days
191
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Basic Information
- Device Name
- MODIFICATION TO: SMITHWICK CAROTID SHUNT
- K Number
- K061484
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Mcpherson Enterprises, Inc.
- Date Received
- May 30, 2006
- Decision Date
- December 7, 2006
- Product Code
- DXC
- 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 |
|---|---|---|---|
| DXC | Clamp, Vascular | FDA class 2 | Cardiovascular |
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