Clearance Summary
HCI GENERAL PURPOSE CATHETER STYLET received FDA 510(k) clearance under submission number K870014, sponsored by Health Care Innovations, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General, Plastic Surgery review panel. The statutory decision date of record is 1987-02-06.
- Submission: K870014
- Applicant / Sponsor: Health Care Innovations, Inc.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1987-02-06
Classification & Regulation
This clearance is catalogued under FDA product code KGZ and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.