Vivalith II 301 Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K844334
Overview
The Vivalith II 301 Pulse Generator is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It is intended for patients requiring permanent pacing to correct bradycardia or other conduction disorders, ensuring consistent and reliable cardiac output.
This device is supplied as a reusable, implantable component within a cardiovascular surgical setting and is regulated under FDA 510(k) clearance (K844334) under the Substantially Equivalent decision. It falls under regulation 870.3610 and is classified as a high-risk, life-sustaining device, requiring strict adherence to implant protocols. No MRI safety or sterility specifications are noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK844334 | Date10 Jan 1985 | 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- Withdrawn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 clinical conditions is the Vivalith II 301 Pulse Generator designed to address in patients?
The Vivalith II 301 Pulse Generator is specifically designed to regulate cardiac rhythm for patients with bradycardia or conduction disorders that require permanent pacing. It delivers electrical impulses to maintain consistent and reliable cardiac output, ensuring stable heart function in eligible patients.
Is the Vivalith II 301 Pulse Generator intended for single-use or reusable applications?
The device is explicitly described as a reusable component, intended for implantation within a cardiovascular surgical setting. It is not labeled as single-use, meaning it can be used across multiple patients after proper sterilization and maintenance protocols are followed.
What regulatory pathway was followed for FDA clearance of this device, and how does it classify under medical device regulations?
The Vivalith II 301 Pulse Generator received FDA clearance through a 510(k) submission (K844334) under the Substantially Equivalent (SESE) decision, classified as a Class III device (high-risk, life-sustaining) under regulation 870.3610. This pathway confirms its status as a critical implantable pacemaker pulse-generator.
Are there any specific storage or handling requirements mentioned for this device?
The provided data does not explicitly detail storage or handling specifications (e.g., temperature, humidity, or shelf life). However, as a reusable implantable device, it must adhere to standard surgical protocols for sterilization and storage to prevent contamination before and after use in cardiovascular procedures.
What medical specialty is primarily responsible for the use of this device, and how is it categorized in regulatory records?
The device is categorized under the Cardiovascular medical specialty in regulatory records, indicating its primary use in procedures involving heart rhythm management. It falls under product code DXY and is listed in the OpenFDA database as an Implantable Pacemaker Pulse-Generator, aligning with its intended application in cardiac electrophysiology.