510(k) K253688
K253688 is an FDA 510(k) premarket notification submitted by Bayer Medical Care, Inc. for the device "MEDRAD® Imaging Bulk Package Transfer Spike". The FDA issued a decision of Substantially Equivalent on June 12, 2026. The device falls under product code PQH (Iodinated Contrast Media Transfer Tubing Set), a Class II device regulated under 21 CFR 880.5440. Bayer Medical Care, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 12, 2026
- Date Received
- November 21, 2025
- 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.