Clearance Summary
BIPOLAR LEAD ADAPTOR, MODEL BA-415 received FDA 510(k) clearance under submission number K790218, sponsored by Pacesetter Systems. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1979-08-10.
- Submission: K790218
- Applicant / Sponsor: Pacesetter Systems
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.3620
- Decision date: 1979-08-10
Classification & Regulation
This clearance is catalogued under FDA product code DTD and 21 CFR 870.3620, within the Cardiovascular review panel as a Class II device.