FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
K Number: K131046
·
Decision Jul 18, 2013
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
3
Review Days
94
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Basic Information
- Device Name
- VASCULAIRE COMPRESSION SYSTEM, VASCULAIRE SLEEVE (FOOT & CALF), VASCULAIRE SLEEVE (CALF)
- K Number
- K131046
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Venous Health Systems, Inc.
- Date Received
- April 15, 2013
- Decision Date
- July 18, 2013
- Product Code
- JOW
- 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 |
|---|---|---|---|
| JOW | Sleeve, Limb, Compressible | FDA class 2 | Cardiovascular |
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