Clearance Summary
VENTICIS II received FDA 510(k) clearance under submission number K863778, sponsored by Cis-Us, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1986-10-27.
- Submission: K863778
- Applicant / Sponsor: Cis-Us, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1390
- Decision date: 1986-10-27
Classification & Regulation
This clearance is catalogued under FDA product code IYT and 21 CFR 892.1390, within the Radiology review panel as a Class II device.