Clearance Summary
Reprocessed PentaRay Nav eco High-Density Mapping Catheter received FDA 510(k) clearance under submission number K201806, sponsored by Sterilmed Inc. (Johnson and Johnson). The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2021-06-23.
- Submission: K201806
- Applicant / Sponsor: Sterilmed Inc. (Johnson and Johnson)
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1220
- Decision date: 2021-06-23
Classification & Regulation
This clearance is catalogued under FDA product code MTD and 21 CFR 870.1220, within the Cardiovascular review panel as a Class II device.