Pacemakers, Vitatron's
by Vitatron Medical BV 510(k)
Active
510(k) K760669
Overview
This device is an Implantable Pacemaker Pulse-Generator, a Class III medical device designed to regulate abnormal heart rhythms by delivering timed electrical impulses to the heart muscle. It is intended for patients experiencing bradycardia or other cardiac conduction disorders requiring artificial pacing to maintain proper heart function.
The Pacemakers, Vitatron’s, are implanted surgically and are intended for single-patient use. They are regulated under FDA 510(k) clearance (K760669) and fall under regulation number 870.3610, classified under the Cardiovascular specialty. No details regarding MRI safety, sterility, or reusable components are provided in the specifications.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760669 | Date12 Nov 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- Withdrawn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 Vitatron Medical BV
Questions
What specific heart conditions are these pacemakers designed to treat, and how do they work?
These pacemakers are designed to address bradycardia and other cardiac conduction disorders where the heart beats too slowly or irregularly. They function by delivering timed electrical impulses to the heart muscle, helping to maintain proper heart rhythm and function in patients who require artificial pacing.
Are these pacemakers intended for reuse or are they single-use devices?
The documentation explicitly states that these pacemakers are intended for single-patient use, meaning each device is meant to be implanted in one individual and is not designed for reuse.
How are these pacemakers regulated in the United States, and what does that mean for clinicians?
These pacemakers are regulated under the FDA’s 510(k) clearance process, specifically under clearance number K760669, and fall under the Cardiovascular specialty (product code DXY). This means the device has been deemed substantially equivalent to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use in treating bradycardia and conduction disorders.
What storage or handling considerations should be taken into account for these pacemakers?
The provided data does not specify storage conditions or handling requirements for these pacemakers. Clinicians should follow standard sterile implant protocols for Class III devices, as these pacemakers are implanted surgically. Always refer to manufacturer guidelines for proper storage and preparation.