Clearance Summary
ELECATH MULTI-PURPOSE ARTERIAL SURGER received FDA 510(k) clearance under submission number K790444, sponsored by Electro-Catheter Corp.. 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 1979-06-11.
- Submission: K790444
- Applicant / Sponsor: Electro-Catheter Corp.
- Clearance pathway: Traditional
- Review panel: General, Plastic Surgery
- Device class: Class I
- Regulation citation: 21 CFR 878.4200
- Decision date: 1979-06-11
Classification & Regulation
This clearance is catalogued under FDA product code GBA and 21 CFR 878.4200, within the General, Plastic Surgery review panel as a Class I device.