Clearance Summary
ELECATH PORTAL VEIN/BILIARY DRAIN ASSM received FDA 510(k) clearance under submission number K821488, sponsored by Electro-Catheter Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Physical Medicine review panel. The statutory decision date of record is 1982-05-28.
- Submission: K821488
- Applicant / Sponsor: Electro-Catheter Corp.
- Clearance pathway: Traditional
- Review panel: Physical Medicine
- Device class: Class I
- Regulation citation: 21 CFR 890.3920
- Decision date: 1982-05-28
Classification & Regulation
This clearance is catalogued under FDA product code KNN and 21 CFR 890.3920, within the Physical Medicine review panel as a Class I device.