Clearance Summary
MEDRAD MARK 7 ARTERION INJECTION SYSTEM / SYRINGE, TWIST & GO SYRINGE received FDA 510(k) clearance under submission number K132928, sponsored by Medrad, Inc. / Bayer Medical Care, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2014-01-23.
- Submission: K132928
- Applicant / Sponsor: Medrad, Inc. / Bayer Medical Care, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2014-01-23
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.