FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
WEXLER VASCULAR CLAMP SERIES
K Number: K110148
·
Decision Apr 19, 2011
Classifications
1
FEI Numbers
186
Registration Numbers
186
Same Product Code
203
Applicant Total
3
Review Days
91
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Basic Information
- Device Name
- WEXLER VASCULAR CLAMP SERIES
- K Number
- K110148
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Microsurgical Laboratories,Inc.Dba Wexler Surgical
- Date Received
- January 18, 2011
- Decision Date
- April 19, 2011
- 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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