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510(k) K161723

ulrich Transfer Set by Ulrich GmbH & Co. KG — Product Code PQH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2016
Date Received
June 22, 2016
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.

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Other clearances for product code PQH

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