Permathane 865 & 867 Unipolar Polyureth
by Pacesetter Systems 510(k)
Active
510(k) K843703
Overview
This device is a pacemaker lead adaptor designed to interface with ventricular pacing leads. It functions as a connector component within cardiovascular pacing systems, facilitating the transmission of electrical impulses between the pacemaker generator and the lead.
The device is supplied by Pacesetter Systems and is intended for use in clinical settings involving cardiac pacing. It is classified under product code DTD and was reviewed under the cardiovascular advisory committee. The device is associated with models 865 and 867 and was cleared through the FDA 510(k) process under k-number K843703.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK843703 | Date8 Jan 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- DTD
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.3620
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Pacesetter Systems
Questions
What is the Permathane 865 & 867 Unipolar Polyureth used for?
This device is a pacemaker lead adaptor designed to interface with ventricular pacing leads. It functions as a connector component within cardiovascular pacing systems, facilitating the transmission of electrical impulses between the pacemaker generator and the lead.
Who manufactures the Permathane 865 & 867 Unipolar Polyureth?
The device is supplied by Pacesetter Systems, a manufacturer based in Sylmar, California, USA. It is intended for use in clinical settings involving cardiac pacing.
What models are associated with this device?
The device is associated with models 865 and 867. These models are part of the Permathane Unipolar Polyureth series and were cleared through the FDA 510(k) process under k-number K843703.
How was this device reviewed for regulatory approval?
The device was reviewed under the FDA 510(k) process with the k-number K843703. It was classified under product code DTD and reviewed by the Cardiovascular Advisory Committee. The decision was Substantially Equivalent, indicating it met the criteria for clearance based on comparison to a predicate device.
What is the regulatory classification of this device?
The device is classified as Class 2 under the FDA regulatory framework. It falls under regulation number 870.3620 and is categorized as a Pacemaker Lead Adaptor within the Cardiovascular medical specialty.