Bipolar Asynchronous Pulse Generator
510(k) K770198
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770198 | Date7 Feb 1977 | 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- Withdrawn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, 20 Sep 2026
The Bipolar Asynchronous Pulse Generator is an implantable pacemaker pulse-generator, classified under FDA regulation 870.3610. It delivers periodic electrical pulses to stimulate cardiac contraction, serving as a substitute for the heart’s natural pacing system to address intermittent or continuous cardiac rhythm disorders. This device operates in an asynchronous mode, providing stimulation independent of the patient’s intrinsic heart rhythm.
This device is intended for implantation and is supplied as a reusable component within a pacemaker system. It requires sterile handling and is regulated under FDA 510(k) clearance (K770198), with a classification as a Class III medical device. Storage and use follow standard implantable pacemaker protocols, adhering to manufacturer guidelines for longevity and functionality. No additional regulatory status beyond the stated 510(k) clearance is implied.