510(k) K161723
K161723 is an FDA 510(k) premarket notification submitted by Ulrich GmbH & Co. KG for the device "ulrich Transfer Set". The FDA issued a decision of Substantially Equivalent on December 21, 2016. The device falls under product code PQH (Iodinated Contrast Media Transfer Tubing Set), a Class II device regulated under 21 CFR 880.5440. Ulrich GmbH & Co. KG has at least 10 other 510(k) clearances on record.
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.