Implant Prog Pulse Generator, Unipolar & Bipolar
510(k) K860573
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860573 | Date28 May 1986 | 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- Withdrawn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, classified as a Class III medical device under FDA regulations. It delivers electrical impulses to regulate heart rhythm by stimulating the heart muscle, ensuring proper cardiac function in patients with bradycardia or other conduction disorders. The unipolar and bipolar configurations allow for flexible application depending on patient anatomy and clinical needs.
The pulse generator is intended for surgical implantation beneath the skin, typically in the pectoral region, and is connected to leads placed within the heart. It is supplied sterile and designed for single-use implantation, though the leads may be reusable in some configurations. The device adheres to FDA clearance under 510(k) number K860573, with regulatory classification under DXY product code and compliance with 21 CFR 870.3610. Storage requires adherence to manufacturer guidelines for sterile packaging integrity.