FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
K Number: K130725
·
Decision Apr 17, 2013
Classifications
1
FEI Numbers
16
Registration Numbers
17
Same Product Code
33
Applicant Total
3
Review Days
30
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Basic Information
- Device Name
- MODIFIED ARGYLE POLYURETHANE UMBILICAL VESSEL CATHETER 2.5FR, 3.5FR, 5 FR.
- K Number
- K130725
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Covidien Lp, Formerly Registered AS Kendall
- Date Received
- March 18, 2013
- Decision Date
- April 17, 2013
- Product Code
- FOS
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOS | Catheter, Umbilical Artery | FDA class 2 | General Hospital |
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