Clearance Summary
HEARTNAVIGATOR RELEASE 2.0 received FDA 510(k) clearance under submission number K140138, sponsored by Philips Medical Systems Nederland B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2014-06-10.
- Submission: K140138
- Applicant / Sponsor: Philips Medical Systems Nederland B.V.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1650
- Decision date: 2014-06-10
Classification & Regulation
This clearance is catalogued under FDA product code OWB and 21 CFR 892.1650, within the Radiology review panel as a Class II device.