Clearance Summary
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER received FDA 510(k) clearance under submission number K895597, sponsored by Vas-Cath, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1990-09-12.
- Submission: K895597
- Applicant / Sponsor: Vas-Cath, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5200
- Decision date: 1990-09-12
Classification & Regulation
This clearance is catalogued under FDA product code FOZ and 21 CFR 880.5200, within the General Hospital review panel as a Class II device.