Clearance Summary
Reconnaissance PV .018 OTW Digital IVUS Catheter received FDA 510(k) clearance under submission number K200410, sponsored by Philips Image Guided Therapy Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-05-22.
- Submission: K200410
- Applicant / Sponsor: Philips Image Guided Therapy Corporation
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1200
- Decision date: 2020-05-22
Classification & Regulation
This clearance is catalogued under FDA product code OBJ and 21 CFR 870.1200, within the Cardiovascular review panel as a Class II device.