Phoenix Models 250/251 Pulse Generators
by Pacesetter Systems 510(k)
Active
510(k) K855081
Overview
The Phoenix Models 250/251 Pulse Generators are implantable pacemaker pulse-generators, designed to regulate cardiac rhythm by delivering electrical impulses to the heart. These devices are classified as Class III medical devices under FDA regulation 870.3610, indicating their high-risk, life-sustaining nature within the cardiovascular specialty.
These pulse generators are intended for single-use implantation and are regulated under FDA 510(k) clearance (K855081), with a decision of Substantially Equivalent (SESE) issued in 1986. Supplied sterile and intended for surgical implantation, they fall under the product code DXY and are reviewed by the Cardiovascular (CV) advisory committee. No additional regulatory status beyond the stated FDA 510(k) clearance is implied.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK855081 | Date7 Mar 1986 | 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- Withdrawn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
Are the Phoenix Models 250/251 Pulse Generators reusable or intended for single-use only?
The Phoenix Models 250/251 Pulse Generators are explicitly designed for single-use implantation only. This is confirmed by the manufacturer’s description, which states they are supplied sterile and intended for surgical implantation without mention of reuse.
What regulatory pathway was followed for FDA clearance of these pulse generators?
These devices were cleared via the FDA 510(k) pathway under clearance number K855081, with a Substantially Equivalent (SESE) determination issued in 1986. The review was conducted by the Cardiovascular (CV) advisory committee and classified under product code DXY, reflecting their high-risk, life-sustaining nature as Class III devices.
How are the Phoenix Models 250/251 Pulse Generators supplied, and what does this imply for handling?
They are supplied sterile and intended for surgical implantation, meaning they must be handled under aseptic conditions. The sterile packaging ensures they are ready for immediate use in the operating room without additional sterilization, reducing contamination risk.
What medical specialty does this device fall under, and why is this relevant?
The Phoenix Models 250/251 Pulse Generators are categorized under the Cardiovascular specialty, as indicated by their product code (DXY) and advisory committee review (CV). This classification highlights their role in regulating cardiac rhythm, making them critical for electrophysiology and cardiology practices.
Are there any specific storage requirements mentioned for these pulse generators?
While the provided data does not detail storage conditions, the devices are sterile and single-use, implying they should be stored in their original packaging in a clean, dry environment to preserve sterility until implantation. Avoid exposure to extreme temperatures or moisture to maintain device integrity.