Clearance Summary
BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP received FDA 510(k) clearance under submission number K982538, sponsored by Belmont Instrument Corp.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-10-02.
- Submission: K982538
- Applicant / Sponsor: Belmont Instrument Corp.
- Clearance pathway: Special
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3535
- Decision date: 1998-10-02
Classification & Regulation
This clearance is catalogued under FDA product code DSP and 21 CFR 870.3535, within the Cardiovascular review panel as a Class II device.