Clearance Summary
PALJET-B received FDA 510(k) clearance under submission number K973663, sponsored by Golden Gate Bio-Device. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1998-02-10.
- Submission: K973663
- Applicant / Sponsor: Golden Gate Bio-Device
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2360
- Decision date: 1998-02-10
Classification & Regulation
This clearance is catalogued under FDA product code DRX and 21 CFR 870.2360, within the Cardiovascular review panel as a Class II device.