Clearance Summary
0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter received FDA 510(k) clearance under submission number K183043, sponsored by Imperative Care, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2019-04-17.
- Submission: K183043
- Applicant / Sponsor: Imperative Care, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2019-04-17
Classification & Regulation
This clearance is catalogued under FDA product code NRY and 21 CFR 870.1250, within the Cardiovascular review panel as a Class II device.