Pulse Generator, Model 5997
510(k) K781252
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK781252 | Date3 Oct 1978 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Full name
- Generator, Pulse, Model 5997
- 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
Overview
AI-generated summary, 18 Sep 2026
The Pulse Generator, Model 5997 is an Implantable Pacemaker Pulse-Generator, classified under product code DXY. This device is designed to deliver electrical impulses to regulate heart rhythm in patients with bradycardia or other cardiac conduction disorders, ensuring consistent and reliable pacing support for sustained cardiac function.
Intended for surgical implantation, the Model 5997 is a reusable, Class III medical device subject to FDA 510(k) clearance (K781252) under the Cardiovascular advisory committee. It requires sterile handling and is regulated under the Implantable Pacemaker Pulse-Generator nomenclature, adhering to strict manufacturing and performance standards for life-sustaining devices. Storage and use must comply with medical device regulations to ensure patient safety and device efficacy.
Other devices from Medtronic Vascular, Inc.
Questions
AI-generated answers, 18 Sep 2026
What is the primary purpose of the Pulse Generator, Model 5997, and how does it function in a clinical setting?
The Pulse Generator, Model 5997, is designed to regulate heart rhythm by delivering electrical impulses to patients with bradycardia or cardiac conduction disorders. It serves as an implantable pacemaker, providing consistent pacing support to maintain stable cardiac function. This device is surgically implanted and works by stimulating the heart muscle to contract at a controlled rate when the natural electrical system fails.
Is the Pulse Generator, Model 5997, intended for single-use or can it be reused after implantation?
The Pulse Generator, Model 5997, is explicitly described as a reusable device. While it is implanted within the patient, the device itself is not disposable. However, sterile handling is required during surgical implantation to prevent infection, as it is classified under strict medical device regulations for life-sustaining implants.
What regulatory pathway was followed for FDA clearance of this device, and which advisory committee was involved?
The Pulse Generator, Model 5997, underwent a Traditional 510(k) review and was determined to be substantially equivalent to a predicate device. It was cleared under the Cardiovascular (CV) advisory committee and assigned the product code DXY, reflecting its classification as an Implantable Pacemaker Pulse-Generator. The clearance decision (K781252) was made in 1978, ensuring compliance with FDA standards for life-sustaining devices.
How should the Pulse Generator, Model 5997, be stored to maintain its integrity and functionality?
While the data does not specify exact storage conditions, the device is classified as Class III and requires compliance with medical device regulations to ensure safety and efficacy. Since it is an implantable device, it must be handled under sterile conditions during implantation, and storage should follow manufacturer guidelines to prevent contamination or damage. Always refer to Medtronic’s official instructions for proper storage protocols.
What medical specialty is primarily responsible for the use and management of this device?
The Pulse Generator, Model 5997, falls under the Cardiovascular medical specialty, as indicated by its regulatory classification and intended use for pacing-related cardiac disorders. Electrophysiologists, cardiologists, and cardiac surgeons are typically involved in its implantation, programming, and long-term management to ensure optimal patient outcomes.