Clearance Summary
ALP 501 RB PUMP SYSTEM received FDA 510(k) clearance under submission number K112311, sponsored by Currie Medical Specialties, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2011-09-01.
- Submission: K112311
- Applicant / Sponsor: Currie Medical Specialties, Inc.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.5800
- Decision date: 2011-09-01
Classification & Regulation
This clearance is catalogued under FDA product code JOW and 21 CFR 870.5800, within the Cardiovascular review panel as a Class II device.