Clearance Summary
CARDIO METRIC CUSTOM PERFUSION TUBING received FDA 510(k) clearance under submission number K841959, sponsored by Sterile Design, 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 1984-10-19.
- Submission: K841959
- Applicant / Sponsor: Sterile Design, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4390
- Decision date: 1984-10-19
Classification & Regulation
This clearance is catalogued under FDA product code DWE and 21 CFR 870.4390, within the Cardiovascular review panel as a Class II device.