FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
K Number: K131966
·
Decision Feb 7, 2014
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
14
Applicant Total
3
Review Days
224
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Basic Information
- Device Name
- TWIN STAR EXTREMITY COMPARTMENT SYNDROME MONITOR AND FLUID COLLECTION CATHETER SYSTEM
- K Number
- K131966
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Twin Star Medical, Inc.
- Date Received
- June 28, 2013
- Decision Date
- February 7, 2014
- Product Code
- LXC
- Advisory Committee
- Unknown
- Review Advisory Committee
- OR
- 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 |
|---|---|---|---|
| LXC | Monitor, Pressure, Intracompartmental | FDA unclassified | Unknown |
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