Clearance Summary
MEDRAD TWIST & GO HIGH PRESSURE CONNECTOR TUBING received FDA 510(k) clearance under submission number K131517, sponsored by Medrad, Inc. / Bayer Medical Care, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2013-08-02.
- Submission: K131517
- Applicant / Sponsor: Medrad, Inc. / Bayer Medical Care, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5440
- Decision date: 2013-08-02
Classification & Regulation
This clearance is catalogued under FDA product code FPK and 21 CFR 880.5440, within the General Hospital review panel as a Class II device.