Clearance Summary
INTRODUCER NEEDLE (SEVERAL SIZES) received FDA 510(k) clearance under submission number K933522, sponsored by Mediziv Medical Products 1987 , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1995-02-21.
- Submission: K933522
- Applicant / Sponsor: Mediziv Medical Products 1987 , Ltd.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.1340
- Decision date: 1995-02-21
Classification & Regulation
This clearance is catalogued under FDA product code DYB and 21 CFR 870.1340, within the Cardiovascular review panel as a Class II device.