Clearance Summary
BSC, SONICATH ULTRA IMAGING CATHETER 3.2F/20MHZ(37410/456221 & BSC, SONICATH ULTRA IMAGING CATHETER 2.9F/20MHZ/37411/ received FDA 510(k) clearance under submission number K970049, sponsored by Cardiovascular Imaging Systems, 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 1997-06-20.
- Submission: K970049
- Applicant / Sponsor: Cardiovascular Imaging Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1997-06-20
Classification & Regulation
This clearance is catalogued under FDA product code ITX and 21 CFR 892.1570, within the Radiology review panel as a Class II device.