510(k) K140136

NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE by Nipro Medical Corporation — Product Code FOZ

K140136 is an FDA 510(k) premarket notification submitted by Nipro Medical Corporation for the device "NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE". The FDA issued a decision of Substantially Equivalent on February 14, 2014. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Nipro Medical Corporation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2014
Date Received
January 17, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type