Clearance Summary
POLYURETHANE INFUSION CATHETER, ALPHA CATH, MODEL PAC20, AND POLYURETHANE INFUSION CATHETER, MULTI DRIP, MODEL PMD20-6 received FDA 510(k) clearance under submission number K061356, sponsored by Advanced Infusion, 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 2006-07-03.
- Submission: K061356
- Applicant / Sponsor: Advanced Infusion, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.6885
- Decision date: 2006-07-03
Classification & Regulation
This clearance is catalogued under FDA product code MED and 21 CFR 880.6885, within the General Hospital review panel as a Class II device.