Cleared Traditional

MEDRAD Imaging Bulk Package Transfer Spike

K200280 · Bayer Medical Care, Inc. · General Hospital

Jul 2020

Decision

177d

Days

Class 2

Risk

About This 510(k) Submission

K200280 is an FDA 510(k) clearance for the MEDRAD Imaging Bulk Package Transfer Spike, a Iodinated Contrast Media Transfer Tubing Set (Class II — Special Controls, product code PQH), submitted by Bayer Medical Care, Inc. (Indianola, US). The FDA issued a Cleared decision on July 30, 2020, 177 days after receiving the submission on February 4, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number	K200280 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 04, 2020
Decision Date	July 30, 2020
Days to Decision	177 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.