Clearance Summary
Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set received FDA 510(k) clearance under submission number K242504, sponsored by Perfuze, Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2024-09-20.
- Submission: K242504
- Applicant / Sponsor: Perfuze, Ltd.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1250
- Decision date: 2024-09-20
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.