VS-1 Model Number 251K Pulse Generator
by Pacesetter Systems 510(k)
Active
510(k) K885267
Overview
The VS-1 Model Number 251K Pulse Generator is an implantable pacemaker pulse-generator, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. It falls under the classification of an implantable pacemaker, a device used to treat bradycardia or other cardiac conduction disorders by maintaining appropriate heart rates.
This device is intended for surgical implantation and is classified as a Class III medical device under FDA regulations. Supplied sterile and intended for single-use, it is regulated under the FDA’s 510(k) clearance process (K885267) and adheres to the medical specialty of cardiovascular care. Storage and handling must comply with sterile medical device protocols to ensure proper functionality and patient safety.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK885267 | Date28 Mar 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- Withdrawn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 purpose of the VS-1 Model Number 251K Pulse Generator, and how does it function in the body?
The VS-1 Model Number 251K Pulse Generator is designed as an implantable pacemaker to regulate cardiac rhythm by delivering controlled electrical impulses to the heart. It is specifically intended for patients with bradycardia or other cardiac conduction disorders, helping to maintain appropriate heart rates by compensating for the heart’s natural electrical signaling issues.
Is the VS-1 Model Number 251K Pulse Generator intended for single-use or reusable applications, and how should it be stored?
The VS-1 Model Number 251K Pulse Generator is supplied sterile and intended for single-use only. To ensure proper functionality and patient safety, it must be stored and handled according to sterile medical device protocols, as specified by the manufacturer.
What regulatory pathway was followed for the VS-1 Model Number 251K Pulse Generator, and which advisory committee reviewed it?
The VS-1 Model Number 251K Pulse Generator was cleared through the FDA’s 510(k) process (K885267) under a Traditional review, with the Cardiovascular (CV) Advisory Committee providing oversight. It is classified as a Class III device under FDA regulations, reflecting its critical role in treating life-threatening cardiac conditions.
What medical specialty is associated with the use of this device, and why is that relevant?
The VS-1 Model Number 251K Pulse Generator is categorized under Cardiovascular specialty care, which aligns with its intended use in treating heart rhythm disorders. This classification ensures that clinicians with expertise in cardiac electrophysiology are the primary users, optimizing patient outcomes and adherence to best practices.