AFP System Pulse Generator Model 261/262
by Pacesetter Systems 510(k)
Active
510(k) K822639
Overview
The AFP System Pulse Generator Model 261/262 is an Implantable Pacemaker Pulse-Generator, designed to deliver electrical impulses for cardiac pacing. It is intended for use in patients requiring artificial cardiac stimulation to regulate heart rhythm, particularly those with bradycardia or other conduction disorders.
This device is supplied as a reusable, implantable component within a pacemaker system and is regulated under FDA 510(k) clearance (K822639) as substantially equivalent to prior generations. It is classified as a Class III medical device under the FDA regulation number 870.3610, reflecting its critical role in life-sustaining or life-supporting functions. The device is intended for surgical implantation and requires sterile handling.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK822639 | Date18 Feb 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Pacesetter Systems
Questions
What is the primary purpose of the AFP System Pulse Generator Model 261/262, and who is it designed for?
The AFP System Pulse Generator Model 261/262 is designed to deliver electrical impulses for cardiac pacing, helping regulate heart rhythm in patients with bradycardia or conduction disorders. It is intended for surgical implantation as part of a pacemaker system to provide artificial cardiac stimulation for life-sustaining or life-supporting functions.
Is the AFP System Pulse Generator Model 261/262 intended for single-use or reusable applications?
The device is explicitly described as a reusable component within a pacemaker system, meaning it is intended for repeated use after proper sterilization and maintenance procedures. It is implanted surgically and requires sterile handling during each use.
How is the regulatory status of this device determined, and what classification does it hold under FDA regulations?
The AFP System Pulse Generator Model 261/262 holds FDA clearance under the 510(k) pathway (K822639) as substantially equivalent to prior generations. It is classified as a Class III medical device under FDA regulation number 870.3610, reflecting its critical role in life-sustaining or life-supporting functions, such as cardiac pacing.
What type of handling and preparation is required for the AFP System Pulse Generator Model 261/262 before implantation?
Since the device is implanted surgically, it must be handled under sterile conditions to prevent infection. The manufacturer’s instructions should be followed for sterilization and preparation, as the device is not pre-sterilized for single-use but is designed for reuse after proper cleaning and sterilization procedures.
What advisory committee reviewed this device, and what was the outcome of its evaluation?
The AFP System Pulse Generator Model 261/262 was reviewed by the FDA Cardiovascular (CV) Advisory Committee as part of its 510(k) submission. The decision was that it is substantially equivalent (SESE) to prior generations, confirming its safety and effectiveness for the intended use in cardiac pacing.