Clearance Summary
TRUCATH.IP received FDA 510(k) clearance under submission number K023368, sponsored by Aortech Critical Care , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 2002-10-28.
- Submission: K023368
- Applicant / Sponsor: Aortech Critical Care , Ltd.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class II
- Regulation citation: 21 CFR 866.5550
- Decision date: 2002-10-28
Classification & Regulation
This clearance is catalogued under FDA product code DFG and 21 CFR 866.5550, within the Immunology review panel as a Class II device.