Lithium Iodide Battery Pacemaker (#201)
by Pacesetter Systems 510(k)
Active
510(k) K761143
Overview
The Lithium Iodide Battery Pacemaker (#201) is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. This device is intended for patients experiencing bradycardia or other conduction disorders requiring chronic cardiac pacing.
This device is supplied as a reusable, implantable system and is regulated under FDA 510(k) clearance (K761143) with a decision dated December 23, 1976. It falls under the Cardiovascular medical specialty and is classified under regulation number 870.3610. The device is intended for surgical implantation and requires sterile handling prior to use.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK761143 | Date23 Dec 1976 | 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- Withdrawn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 types of heart conditions is this pacemaker designed to treat, and how does it work?
This Lithium Iodide Battery Pacemaker (#201) is specifically designed to regulate bradycardia (slow heart rate) and other conduction disorders requiring chronic cardiac pacing. It works by delivering controlled electrical impulses to the heart muscle, helping to maintain a normal heart rhythm when the natural electrical system fails.
Is this device intended for single-use or can it be reused after implantation?
This pacemaker is not single-use—it is designed as a reusable, implantable system for long-term use. Once surgically implanted, it remains in place and is not meant to be removed or reused in another patient.
What regulatory pathway was followed for FDA clearance, and when was the decision made?
The Lithium Iodide Battery Pacemaker (#201) was cleared through the FDA 510(k) pathway under the classification of an Implantable Pacemaker Pulse-Generator (Class III). The decision was made on December 23, 1976, with the clearance number K761143, confirming it as substantially equivalent to prior devices.
How should this device be handled before implantation to ensure sterility?
Since this is an implantable device, it requires sterile handling prior to use to prevent infection. The packaging must be intact, and standard aseptic techniques should be followed during surgical preparation and implantation.
What are the key specifications or identifiers for this model, such as the product code or regulatory classification?
This device is identified by the model number #201 and falls under the FDA product code DXY, classified under regulation number 870.3610 for Implantable Pacemaker Pulse-Generators. It is also associated with multiple FDA registration numbers (e.g., 2017865, 3005334138) for tracking and compliance.