Clearance Summary
MODEL 1148T TRANSVENOUS, SCREW-IN LEAD received FDA 510(k) clearance under submission number K925347, 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 1993-06-10.
- Submission: K925347
- Applicant / Sponsor: Siemens-Pacesetter, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1993-06-10
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.