Cleared Traditional

Liebel-Flarsheim IBP Transfer Set

K193010 · Liebel-Flarsheim Company, LLC · General Hospital
Nov 2020
Decision
386d
Days
Class 2
Risk

About This 510(k) Submission

K193010 is an FDA 510(k) clearance for the Liebel-Flarsheim IBP Transfer Set, a Iodinated Contrast Media Transfer Tubing Set (Class II — Special Controls, product code PQH), submitted by Liebel-Flarsheim Company, LLC (Richmond Heights, US). The FDA issued a Cleared decision on November 18, 2020, 386 days after receiving the submission on October 29, 2019. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K193010 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2019
Decision Date November 18, 2020
Days to Decision 386 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.