Clearance Summary
ELECATH OPEN TIP BIPOLAR PACING CATHETER received FDA 510(k) clearance under submission number K850324, sponsored by Electro-Catheter Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1985-03-27.
- Submission: K850324
- Applicant / Sponsor: Electro-Catheter Corp.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3680
- Decision date: 1985-03-27
Classification & Regulation
This clearance is catalogued under FDA product code LDF and 21 CFR 870.3680, within the Cardiovascular review panel as a Class II device.