Clearance Summary
MEDTRONIC PS MEDICAL BIOGLIDE VASCULAR CATHETER, SNGL LUMEN MODEL NOS 8960 & 8932 received FDA 510(k) clearance under submission number K960055, sponsored by Pudenz-Schulte Medical Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1996-09-30.
- Submission: K960055
- Applicant / Sponsor: Pudenz-Schulte Medical Research Corp.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 1996-09-30
Classification & Regulation
This clearance is catalogued under FDA product code LJS and 21 CFR 880.5970, within the General Hospital review panel as a Class II device.