Clearance Summary
HR POLYURETHANE PICC AND MIDLINE CATHETERS received FDA 510(k) clearance under submission number K964556, sponsored by Johnson & Johnson Medical, Inc.. 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 1997-04-16.
- Submission: K964556
- Applicant / Sponsor: Johnson & Johnson Medical, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5970
- Decision date: 1997-04-16
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.