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510(k) K193010

Liebel-Flarsheim IBP Transfer Set by Liebel-Flarsheim Company, LLC — Product Code PQH

K193010 is an FDA 510(k) premarket notification submitted by Liebel-Flarsheim Company, LLC for the device "Liebel-Flarsheim IBP Transfer Set". The FDA issued a decision of Substantially Equivalent on November 18, 2020. The device falls under product code PQH (Iodinated Contrast Media Transfer Tubing Set), a Class II device regulated under 21 CFR 880.5440. Liebel-Flarsheim Company, LLC has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 2020
Date Received
October 29, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Iodinated Contrast Media Transfer Tubing Set
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

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.

Other clearances by Liebel-Flarsheim Company, LLC

  • K152361 — OptiOne Single-Head Contrast Delivery System with Pedestal; with Ceiling Suspens (January 14, 2016)

Other clearances for product code PQH

  • K253688 — MEDRAD® Imaging Bulk Package Transfer Spike (June 12, 2026)
  • K200280 — MEDRAD Imaging Bulk Package Transfer Spike (July 30, 2020)
  • K173913 — MEDRAD® Imaging Bulk Package Transfer Set (May 4, 2018)
  • K161723 — ulrich Transfer Set (December 21, 2016)
  • K133147 — BRACCO INJEENERING TRANSFER SET (June 20, 2014)

FDA data resources