Clearance Summary
AMBULATORY INFUSION PUMP SYSTEM AND SOLUTION SETS received FDA 510(k) clearance under submission number K932408, sponsored by Baxter Healthcare Corp. The device was reviewed via the Traditional premarket notification pathway and assigned to the Gastroenterology, Urology review panel. The statutory decision date of record is 1993-09-28.
- Submission: K932408
- Applicant / Sponsor: Baxter Healthcare Corp
- Clearance pathway: Traditional
- Review panel: Gastroenterology, Urology
- Device class: Class I
- Regulation citation: 21 CFR 876.4730
- Decision date: 1993-09-28
Classification & Regulation
This clearance is catalogued under FDA product code FFN and 21 CFR 876.4730, within the Gastroenterology, Urology review panel as a Class I device.