FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AIRCAST VENAFLOW ELITE SYSTEM
K Number: K130722
·
Decision Jun 20, 2013
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
12
Review Days
94
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Basic Information
- Device Name
- AIRCAST VENAFLOW ELITE SYSTEM
- K Number
- K130722
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Djo, LLC
- Date Received
- March 18, 2013
- Decision Date
- June 20, 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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| K143551 | Compex Wireless USA | Apr 28, 2015 | Substantially Equivalent |
| K132284 | VECTRA NEO CLINICAL THERAPY SYSTEM | Apr 10, 2014 | Substantially Equivalent |
| K124016 | EMPI PHOENIX | May 6, 2013 | Substantially Equivalent |
| K122499 | AIRCAST VENAFLOW ELITE SYSTEM | Oct 18, 2012 | Substantially Equivalent |