AFP Model 262T Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K884733
Overview
The AFP Model 262T Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is classified as a Class III medical device under FDA regulations, intended for patients requiring artificial cardiac pacing to manage bradycardia or other conduction disorders.
This device is supplied as a reusable, implantable component and must be used in a sterile operating environment by qualified healthcare professionals. It is regulated under FDA 510(k) clearance (K884733) and adheres to the specifications outlined in regulation number 870.3610. The pulse generator is intended for surgical implantation and requires proper handling, storage, and disposal in accordance with medical device guidelines.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK884733 | Date10 Feb 1989 | 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- Withdrawn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 clinical purpose of the AFP Model 262T Pulse Generator, and how does it function within the body?
The AFP Model 262T Pulse Generator is designed to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is intended for patients with bradycardia or conduction disorders who require artificial cardiac pacing. By stimulating the heart muscle electrically, it helps maintain a normal heartbeat and ensures proper cardiac function.
Is the AFP Model 262T Pulse Generator intended for single-use or can it be reused after implantation?
The AFP Model 262T Pulse Generator is explicitly described as a reusable, implantable component. However, it must be used in a sterile operating environment during surgical implantation and handled according to medical device guidelines to ensure patient safety and device integrity.
What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its clinical use?
The AFP Model 262T Pulse Generator received FDA clearance through a 510(k) submission, classified as a Class III medical device under FDA regulations. The clearance was determined to be Substantially Equivalent (SE) to a predicate device, meaning it was evaluated for safety and effectiveness based on existing standards. This pathway ensures the device meets regulatory requirements for use in managing bradycardia or conduction disorders.
How should the AFP Model 262T Pulse Generator be stored, and are there any specific handling instructions?
While the provided data does not specify storage conditions in detail, the device must be handled in accordance with standard medical device guidelines to maintain sterility and functionality. Since it is implanted in a sterile operating environment, it should be stored in a clean, controlled setting—protected from contamination, moisture, and physical damage—until surgical use. Always follow manufacturer instructions for optimal preservation.