Clearance Summary
IRL VASOSCAN(TM) INTRAVASCULAR ULTRASOUND CATHETER received FDA 510(k) clearance under submission number K982208, sponsored by Jomed Imaging , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1999-08-27.
- Submission: K982208
- Applicant / Sponsor: Jomed Imaging , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1570
- Decision date: 1999-08-27
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.