Clearance Summary
SAFE MAXI HOLLOW FIBER OXYGENATOR, MODEL 016010 received FDA 510(k) clearance under submission number K013038, sponsored by Polystan A/S. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2002-08-14.
- Submission: K013038
- Applicant / Sponsor: Polystan A/S
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.4350
- Decision date: 2002-08-14
Classification & Regulation
This clearance is catalogued under FDA product code DTZ and 21 CFR 870.4350, within the Cardiovascular review panel as a Class II device.