FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DEVON CIRONA 6100 DVT
K Number: K130571
·
Decision Apr 9, 2013
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
11
Review Days
36
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Basic Information
- Device Name
- DEVON CIRONA 6100 DVT
- K Number
- K130571
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5800
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Devon Medical, Inc.
- Date Received
- March 4, 2013
- Decision Date
- April 9, 2013
- Product Code
- JOW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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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Other Clearances by Devon Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K140634 | extriCARE 2400 NPWT System with extriCARE 2400 NPWT Pump and extriCARE NPWT Foam Dressing Kit | Sep 19, 2014 | Substantially Equivalent |
| K132225 | EXTRICARE | May 15, 2014 | Substantially Equivalent |
| K131464 | EXTRICARE NPWT FOOT DRESSING | Aug 13, 2013 | Substantially Equivalent |
| K131743 | CIRONA DVT FOOT GARMENT | Jul 1, 2013 | Substantially Equivalent |
| K123959 | CIRCUFLOW 5150 | Feb 28, 2013 | Substantially Equivalent |
| K123647 | CIRCUFLOW 5208 SEQUENTIAL COMPRESSION DEVICE | Feb 14, 2013 | Substantially Equivalent |
| K102582 | ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE | Oct 7, 2010 | Substantially Equivalent |
| K101523 | CIRCUFLOW 5200 SEQUENTIAL COMPRESSION DEVICE | Jun 17, 2010 | Substantially Equivalent |
| K100446 | CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE | Mar 5, 2010 | Substantially Equivalent |
| K090664 | DEVON ACCUBP CUFF | Mar 23, 2009 | Substantially Equivalent |