Clearance Summary
OPTIBOLUS received FDA 510(k) clearance under submission number K031339, sponsored by Mallinckrodt Inc., Liebel-Flarsheim Business. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2003-07-11.
- Submission: K031339
- Applicant / Sponsor: Mallinckrodt Inc., Liebel-Flarsheim Business
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1650
- Decision date: 2003-07-11
Classification & Regulation
This clearance is catalogued under FDA product code DXT and 21 CFR 870.1650, within the Cardiovascular review panel as a Class II device.