Minilith and Microlith Implantable Pacemaker Pulse-Generator
510(k) K790276
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790276 | Date26 Feb 1979 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Minilith and Microlith
- 510(k) Number
- FDA Product Code
- DXY
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3610
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
The Minilith and Microlith are implantable pacemaker pulse-generators designed to regulate cardiac rhythm in patients with bradycardia or conduction disorders. These devices deliver electrical impulses to stimulate the heart muscle, ensuring proper pacing and maintaining normal heart function when the natural pacemaker is insufficient or dysfunctional.
These devices are intended for surgical implantation and are classified as Class III medical devices under FDA regulation 870.3610. Supplied sterile and intended for single-use, they are regulated through a 510(k) clearance process (K790276) and are manufactured by Cardiac Pacemakers, Inc. Specific models include variations such as 505, 605, 507, 607, and 703, with detailed specifications available in the original submission. Compliance with FDA guidelines ensures their safety and performance for cardiovascular applications.