510(k) K173913
K173913 is an FDA 510(k) premarket notification submitted by Bayer U.S., LLC for the device "MEDRAD® Imaging Bulk Package Transfer Set". The FDA issued a decision of Substantially Equivalent on May 4, 2018. The device falls under product code PQH (Iodinated Contrast Media Transfer Tubing Set), a Class II device regulated under 21 CFR 880.5440.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 4, 2018
- Date Received
- December 22, 2017
- 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.