Pulse Generator 689, 689B & 689L
510(k) K841225
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK841225 | Date3 Dec 1984 | 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- Withdrawn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
- 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
This device is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders. It serves as the power source and control unit for pacing systems, ensuring consistent and programmable stimulation of the heart chambers as required by clinical indications.
The Pulse Generator 689, 689B & 689L is intended for implantation within the body and is classified as a Class III medical device under FDA regulations (870.3610). These models are reusable and must be handled under sterile conditions during surgical procedures. The devices are regulated through FDA 510(k) clearance (K841225) and are supplied with appropriate packaging for surgical use, adhering to cardiovascular medical specialty standards.