Cleared Special

NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE

K140136 · Nipro Medical Corporation · General Hospital

Feb 2014

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K140136 is an FDA 510(k) clearance for the NIPRO SAFETOUCH PSV SCALP VEIN SET WITH SAFETY DEVICE, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on February 14, 2014, 28 days after receiving the submission on January 17, 2014. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K140136 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 17, 2014
Decision Date	February 14, 2014
Days to Decision	28 days
Submission Type	Special
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200