FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COMBAT READY CLAMP
K Number: K130482
·
Decision Apr 29, 2013
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
198
Applicant Total
3
Review Days
63
Basic Information
- Device Name
- COMBAT READY CLAMP
- K Number
- K130482
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- COMBAT MEDICAL SYSTEMS, LLC
- Date Received
- February 25, 2013
- Decision Date
- April 29, 2013
- 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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