Implantable Pacemaker Pulse Gen, Models 241 & 242
by Pacesetter Systems 510(k)
Active
510(k) K823878
Overview
This device is an implantable pacemaker pulse generator, classified under the nomenclature for cardiac rhythm management devices. It is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, compensating for abnormal electrical activity and maintaining proper cardiac pacing in patients with bradycardia or other conduction disorders.
The pulse generator is intended for surgical implantation and is supplied sterile for single-use. It operates within Class III regulatory classification under FDA 510(k) clearance (K823878) and is approved for use in cardiovascular applications. Models 241 and 242 are regulated under FDA regulation number 870.3610, with no indication of MRI compatibility or reusable design. Storage and handling must adhere to sterile medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823878 | Date24 Mar 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- Withdrawn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
Are the IMPLANTABLE PACEMAKER PULSE GENERATOR models 241 and 242 designed for reuse or single-use, and how should they be handled during surgery?
Models 241 and 242 are supplied sterile for single-use only. Since they are intended for surgical implantation, they must be handled as sterile medical devices, following standard sterile field protocols to prevent contamination before and during use.
What types of heart conditions are these devices intended to address, and how do they function?
These pulse generators are designed to regulate heart rhythm by delivering electrical impulses to the heart muscle, specifically addressing bradycardia or conduction disorders where the heart’s natural electrical activity is impaired. They compensate for abnormal rhythms by maintaining proper pacing.
How are these devices regulated by the FDA, and what does the clearance type indicate?
The IMPLANTABLE PACEMAKER PULSE GENERATOR (models 241 & 242) holds a Traditional 510(k) clearance (K823878) under FDA regulation 870.3610, classified as a Class III device. The clearance type indicates a review process where the manufacturer demonstrated substantial equivalence to a legally marketed predicate device, ensuring safety and effectiveness for cardiovascular applications.
Are there any special storage requirements for these devices beyond standard sterile medical device protocols?
While the data does not specify unique storage conditions beyond general sterile medical device protocols, the devices must be stored in a way that maintains sterility until use. Since they are single-use and implanted surgically, adherence to manufacturer guidelines for packaging integrity and environmental controls is critical.