Clearance Summary
MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD received FDA 510(k) clearance under submission number K885240, sponsored by Tpl-Cordis, 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 1989-02-10.
- Submission: K885240
- Applicant / Sponsor: Tpl-Cordis, Inc.
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class III
- Regulation citation: 21 CFR 870.3680
- Decision date: 1989-02-10
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.