Cardiac Pacemaker C4000, C1000 Ser.
by Vitatron Medical BV 510(k)
Active
510(k) K791921
Overview
The Cardiac Pacemaker C4000, C1000 Series is an Implantable Pacemaker Pulse-Generator, designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. This device is intended for patients with bradycardia or other cardiac conduction disorders requiring chronic pacing support.
These pacemakers are implanted surgically and are classified as Class III medical devices under FDA regulations. The C4000 and C1000 Series are single-use, non-sterile devices (sterilized prior to implantation) and must be handled under aseptic conditions. They are regulated under FDA 510(k) clearance (K791921) with a decision of Substantially Equivalent, issued in 1979. No MRI safety information is specified in the data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK791921 | Date26 Oct 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- Withdrawn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 Vitatron Medical BV
Questions
What types of heart conditions is this pacemaker designed to treat, and how does it work?
The Cardiac Pacemaker C4000 and C1000 Series is specifically designed to treat patients with bradycardia or other cardiac conduction disorders that require chronic pacing support. It works by delivering regulated electrical impulses to the heart muscle, helping to maintain a normal heart rhythm when the heart’s natural conduction system is impaired.
Is this device single-use or reusable, and what precautions should be taken during handling?
The C4000 and C1000 Series pacemakers are classified as single-use devices, though they are sterilized prior to implantation. Since they are non-sterile before use, they must be handled under strict aseptic conditions to prevent contamination before surgical implantation.
What regulatory pathway was followed for FDA clearance, and when was the decision made?
This device was cleared through the FDA’s 510(k) pathway, specifically under the Traditional review process, with a decision of *Substantially Equivalent* to a predicate device. The clearance (K791921) was issued on October 26, 1979, following a submission received on September 25, 1979.
Are there multiple models or sizes available for this pacemaker series?
The data provided lists multiple FEI (Final Establishment Identification) numbers under the C4000 and C1000 Series, which typically correspond to different lot or batch identifiers rather than distinct physical models or sizes. However, no specific size variations (e.g., battery capacity, lead configurations) are detailed in the available information.
Can this pacemaker be used in patients who require MRI scans, or is there any safety information available?
The provided data does not specify any MRI safety information for the C4000 or C1000 Series pacemakers. Patients with implanted cardiac devices should consult their clinician before undergoing MRI procedures, as standard pacemakers may pose risks in magnetic fields.