Pulse Generator, Bipolar, Model #604
510(k) K770715
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK770715 | Date25 Apr 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- Withdrawn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
- Full name
- Generator, Pulse, Bipolar, Model #604
- 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 bipolar electrical impulses to regulate cardiac rhythm in patients with bradycardia or other conduction disorders, ensuring consistent pacing of the heart through implanted electrodes.
The Model #604 is intended for permanent implantation within the body and is designed for single-use after initial deployment. It is non-sterile as supplied but must be handled under sterile conditions prior to implantation. The device is MRI-unsafe and requires careful positioning to avoid interference with cardiac pacing. Authorized under FDA 510K clearance (K770715), it adheres to regulatory standards for cardiovascular implantable devices.