Cleared Special

SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER

K113429 · Nipro Medical Corporation · General Hospital

Mar 2012

Decision

112d

Days

Class 2

Risk

About This 510(k) Submission

K113429 is an FDA 510(k) clearance for the SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER, 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 March 12, 2012, 112 days after receiving the submission on November 21, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K113429 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 21, 2011
Decision Date	March 12, 2012
Days to Decision	112 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