Clearance Summary
Reprocessed BRK Transseptal Needle received FDA 510(k) clearance under submission number K192998, sponsored by Innovative Health, LLC. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2020-07-22.
- Submission: K192998
- Applicant / Sponsor: Innovative Health, LLC
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1390
- Decision date: 2020-07-22
Classification & Regulation
This clearance is catalogued under FDA product code NMK and 21 CFR 870.1390, within the Cardiovascular review panel as a Class II device.