Clearance Summary
PACING LEAD MODEL 1188T received FDA 510(k) clearance under submission number K925038, sponsored by Siemens-Pacesetter, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1994-07-15.
- Submission: K925038
- Applicant / Sponsor: Siemens-Pacesetter, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1994-07-15
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.