Pacemakers, Vitatrons (Series 2000)
by Vitatron Medical BV 510(k)
Active
510(k) K760670
Overview
The Vitatrons (Series 2000) are implantable pacemaker pulse-generators designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. Classified under the nomenclature for Implantable Pacemaker Pulse-Generators, these devices are intended for patients experiencing bradycardia or other conduction disorders requiring cardiac pacing support.
These devices are supplied sterile and intended for single-use implantation by qualified medical professionals in clinical settings. Regulated under FDA 510(k) clearance (K760670) as a Class III device, they adhere to strict premarket approval requirements. No additional storage or handling specifications are noted beyond standard sterile implantable medical device protocols.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760670 | 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- Withdrawn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
Are the Vitatrons (Series 2000) pacemakers designed for patients with specific heart conditions, and if so, which ones?
The Vitatrons (Series 2000) pacemakers are specifically designed to regulate abnormal heart rhythms by delivering electrical impulses to the heart muscle. They are intended for patients experiencing bradycardia (slow heart rate) or other conduction disorders that require cardiac pacing support.
How are the Vitatrons (Series 2000) pacemakers supplied, and what does this mean for their use in a clinical setting?
The Vitatrons (Series 2000) pacemakers are supplied sterile and intended for single-use implantation. This means they are pre-sterilized to ensure safety and must be used once and then discarded, preventing cross-contamination and ensuring compliance with sterile implantable medical device protocols in clinical settings.
What regulatory pathway was followed for the FDA clearance of the Vitatrons (Series 2000) pacemakers, and what does this imply about their safety and efficacy?
The Vitatrons (Series 2000) pacemakers were cleared through the FDA’s 510(k) process, specifically under a Traditional review pathway with a decision of Substantially Equivalent (SESE) by the Cardiovascular (CV) Advisory Committee. This implies that the device was determined to be as safe and effective as a legally marketed predicate device, meeting strict premarket approval requirements for Class III medical devices.
Are there any special storage instructions for the Vitatrons (Series 2000) pacemakers beyond standard sterile implantable medical device protocols?
No additional storage or handling specifications are noted beyond standard sterile implantable medical device protocols. This means they should be stored according to general guidelines for sterile medical devices to maintain their integrity until use.