Cardiac Pacemaker Opus 4000 Models 4043/4044/4063/4066
510(k) K882427
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882427 | Date23 Sep 1988 | 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- Withdrawn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
- Cardiac Pace. Opus 4000 Models 4043/4044/4063/4066
- 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 Cardiac Pacemaker Opus 4000 Models 4043/4044/4063/4066 is an implantable pacemaker pulse generator. It is designed to provide electrical stimulation to the heart when the natural cardiac rhythm is insufficient, ensuring proper heart function in patients with bradycardia or conduction disorders.
These devices are intended for surgical implantation and are classified as Class III under FDA regulations. They are reusable within their intended use cycle and must be handled under sterile conditions. The Opus 4000 series operates under FDA 510(k) clearance (K882427) and is regulated under the medical specialty of cardiovascular devices, adhering to the classification code DXY and regulation number 870.3610.