Vicor Models 410B, 410D, and Modified 410A Pacemaker - 410D
by Telectronics and Cordis Pacing Systems
510(k) K881711
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK881711 | Date26 May 1988 | 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- Withdrawn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
- 510(k) Number
- FDA Product Code
- DXY
- Models / Variants
- 410D
- 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 Vicor Models 410B, 410D, and Modified 410A are implantable pacemaker pulse generators, classified under FDA code DXY. These devices provide a power supply and electronic circuitry to generate periodic electrical pulses, serving as a substitute for the heart’s intrinsic pacing system to manage cardiac rhythm disorders, including both intermittent and continuous abnormalities.
These pacemakers are intended for implantation and are regulated under FDA 510(k) clearance K881711, falling under device class III (870.3610). They are designed for single-use implantation and are not reusable. No specific MRI safety or sterility details are provided in the data, but they are governed by cardiovascular regulatory standards. The models are identified by their unique reference codes (410B, 410D, and Modified 410A) and are registered under multiple FDA registration numbers.
Other devices from Telectronics and Cordis Pacing Systems
Questions
AI-generated answers, 18 Sep 2026
Are these pacemakers designed for reuse or are they single-use devices intended for one-time implantation?
The Vicor Models 410B, 410D, and Modified 410A are explicitly designed for single-use implantation only. The device description confirms they are not intended for reuse, aligning with standard practices for implantable pulse generators to ensure patient safety and sterility.
What specific cardiac rhythm disorders are these pacemakers intended to manage, and how do they function?
These pacemakers are intended to manage cardiac rhythm disorders, including both intermittent and continuous abnormalities, by serving as a substitute for the heart’s intrinsic pacing system. They generate periodic electrical pulses to regulate heartbeats when the natural conduction system fails, ensuring proper cardiac rhythm.
How are these devices supplied, and what should clinicians consider regarding their handling before implantation?
The Vicor Models 410B, 410D, and Modified 410A are implantable pulse generators supplied as sterile devices for surgical implantation. While the data does not specify explicit sterility assurances (e.g., terminal sterilization method), they are governed by cardiovascular regulatory standards, implying adherence to industry best practices for sterility and handling. Clinicians should follow standard aseptic techniques during implantation.
What distinguishes the Vicor Models 410B, 410D, and Modified 410A from each other, and how are they identified?
The models are differentiated by their unique reference codes: 410B, 410D, and Modified 410A. These distinctions likely reflect variations in specifications (e.g., pacing modes, battery life, or programming features), though the provided data does not detail these differences. They are all registered under multiple FDA registration numbers, confirming their individual regulatory tracking.
What regulatory pathway was followed for FDA clearance of these devices, and what does this imply for their safety and efficacy?
These pacemakers were cleared via the FDA 510(k) pathway (K881711), classified under device class III (870.3610) and reviewed by the Cardiovascular (CV) Advisory Committee. The decision was marked as *Substantially Equivalent (SESE)*, meaning they were deemed comparable to legally marketed devices in terms of safety and effectiveness. This pathway ensures rigorous evaluation of implantable cardiac devices.