FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
K Number: K151189
·
Decision Sep 18, 2015
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
349
Applicant Total
4
Review Days
137
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Basic Information
- Device Name
- Cirona 6300 Disposable Deep Vein Thrombosis (DVT) Prevention System
- K Number
- K151189
- 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 Products
- Date Received
- May 4, 2015
- Decision Date
- September 18, 2015
- 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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Other Clearances by Devon Medical Products
| K Number | Device Name | ||
|---|---|---|---|
| K161209 | Cirona 6400 | May 31, 2016 | Substantially Equivalent |
| K151240 | extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 4pc | Jun 9, 2015 | Substantially Equivalent |
| K143362 | extriCARE 3600 Negative Pressure Wound Therapy System 1000cc canister | Feb 3, 2015 | Substantially Equivalent |