Cleared Traditional

ulrich Transfer Set

K161723 · Ulrich GmbH & Co. KG · General Hospital

Dec 2016

Decision

182d

Days

Class 2

Risk

About This 510(k) Submission

K161723 is an FDA 510(k) clearance for the ulrich Transfer Set, a Iodinated Contrast Media Transfer Tubing Set (Class II — Special Controls, product code PQH), submitted by Ulrich GmbH & Co. KG (Ulm, DE). The FDA issued a Cleared decision on December 21, 2016, 182 days after receiving the submission on June 22, 2016. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K161723 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 22, 2016
Decision Date	December 21, 2016
Days to Decision	182 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	PQH — Iodinated Contrast Media Transfer Tubing Set
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5440
Definition	The Iodinated Contrast Media Transfer Set Is Intended To Transfer Iodinated Contrast Media From Imaging Bulk Package Contrast Media In A Controlled Ambient Environment. The Transfer Set Is Intended To Be Used To Directly Fill Multiple Sterile Single Use Syringes From An Imaging Bulk Package Contrast Media Bulk Package Under Controlled Ambient Filling Conditions Such As A Ct Suite.