FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
K Number: K140136
·
Decision Feb 14, 2014
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
34
Review Days
28
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Basic Information
- Device Name
- NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE
- K Number
- K140136
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nipro Medical Corporation
- Date Received
- January 17, 2014
- Decision Date
- February 14, 2014
- Product Code
- FOZ
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
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