Pulse Generator, R Wave Demand
by Pacesetter Systems 510(k)
Active
510(k) K790141
Overview
This device is an Implantable Pacemaker Pulse-Generator, designed to regulate heart rhythm by delivering electrical impulses in response to the body’s natural R-wave signal, ensuring consistent cardiac pacing when intrinsic conduction is insufficient. It is classified as a Class III medical device under FDA regulations, requiring premarket approval due to its critical role in managing life-threatening arrhythmias.
The Pulse Generator, R Wave Demand is intended for implantable use within the cardiovascular system and is supplied as a single-use, sterile device following implantation. It operates under FDA 510(k) clearance (K790141) and adheres to regulatory standards outlined in 21 CFR 870.3610, with no third-party involvement in its distribution. Device specifications align with the DXY product code, and its design is substantiated as substantially equivalent to predicate devices in the cardiovascular category.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK790141 | Date10 Aug 1979 | 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- Withdrawn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 Pulse Generator, R Wave Demand, and how does it function in the body?
The Pulse Generator, R Wave Demand, is designed to regulate heart rhythm by delivering electrical impulses only when the heart’s natural R-wave signal is absent or insufficient. It operates in a demand mode, meaning it senses the body’s intrinsic electrical activity and provides pacing support only when needed, ensuring consistent cardiac pacing for patients with insufficient intrinsic conduction.
Is this device intended for reuse, or is it meant to be implanted as a single-use item?
This device is explicitly intended for single-use following implantation. Once implanted, it is not designed to be removed or reused, aligning with standard practices for implantable pacemaker pulse-generators to ensure patient safety and sterility.
How is the Pulse Generator, R Wave Demand supplied, and what sterility assurances are provided?
The device is supplied as a sterile, single-use implantable pulse-generator. Sterility is maintained for use in the cardiovascular system, ensuring it meets regulatory standards for implantable medical devices to prevent infection or contamination during or after implantation.
What regulatory pathway was followed for this device, and what does that mean for its use?
The Pulse Generator, R Wave Demand was cleared through the FDA 510(k) pathway (K790141) under the classification of a Class III medical device, requiring premarket approval due to its critical role in managing life-threatening arrhythmias. This clearance confirms it is substantially equivalent to predicate devices in the cardiovascular category, adhering to 21 CFR 870.3610.
Are there multiple models or sizes available for this pulse generator, or is it a single standardized unit?
The provided data does not specify multiple models or sizes for this particular Pulse Generator, R Wave Demand. It is described as a standardized implantable pacemaker pulse-generator with no variations mentioned in the regulatory documentation. For exact specifications, consult the manufacturer’s product catalog or technical documentation.