FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
K Number: K113429
·
Decision Mar 12, 2012
Classifications
1
FEI Numbers
212
Registration Numbers
213
Same Product Code
496
Applicant Total
26
Review Days
112
Basic Information
- Device Name
- SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER
- K Number
- K113429
- 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
- November 21, 2011
- Decision Date
- March 12, 2012
- 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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Other Clearances by NIPRO MEDICAL CORPORATION
| K Number | Device Name | ||
|---|---|---|---|
| K161681 | Nipro SafeTouch IV Catheter | Mar 8, 2017 | Substantially Equivalent |
| K160444 | FB-U Hemodialyzer | Feb 8, 2017 | Substantially Equivalent |
| K151141 | Cronus HP - High Pressure Peripheral Balloon Catheter | Jan 14, 2016 | Substantially Equivalent |
| K140191 | ELISIO-H HEMODIALYZER | Apr 14, 2014 | Substantially Equivalent |
| K140136 | NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE | Feb 14, 2014 | Substantially Equivalent |
| K131935 | ELISIO-H HEMODIALYZER, ELISIO-M HEMODIALYZER | Dec 20, 2013 | Substantially Equivalent |
| K131381 | ELISIO-H HEMODIALYZER | Dec 19, 2013 | Substantially Equivalent |
| K132153 | SAFETOUCH PSV WINGED INFUSION SET WITH/WITHOUT FILTER | Dec 5, 2013 | Substantially Equivalent |
| K122952 | NIPRO PUREFLUX-L HEMODIALYZER | Dec 4, 2013 | Substantially Equivalent |
| K131641 | MONOJECT 60ML SYRINGE (LUER LOCK TIP, LUER SLIP TIP, CATHETER TIP) | Aug 28, 2013 | Substantially Equivalent |