Clearance Summary
COAXIAL BIPOLAR PACING ELECTRODE received FDA 510(k) clearance under submission number K822239, sponsored by Burditt & Calkins-Siemens-Elema. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1982-10-04.
- Submission: K822239
- Applicant / Sponsor: Burditt & Calkins-Siemens-Elema
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1982-10-04
Classification & Regulation
This clearance is catalogued under FDA product code DTB and 21 CFR 870.3680, within the Cardiovascular review panel as a Class III device.