Endocardial Firm Lead
by Pacesetter Systems 510(k)
Active
510(k) K850652
Overview
The Endocardial Firm Lead is a pacemaker lead designed for endocardial placement, intended for use within cardiac pacing systems. It delivers electrical stimulation to the heart muscle to regulate heart rhythm in patients requiring pacing therapy. This device is classified as a pacemaker lead adaptor under regulatory frameworks and is specifically engineered for cardiovascular applications.
This lead is supplied as a reusable medical device and is regulated under FDA 510(k) clearance (K850652) with a decision of Substantially Equivalent (SESE). It falls under the classification of Device Type DTD and is governed by regulation number 870.3620. The device is intended for use in clinical settings where cardiac pacing is required, adhering to strict medical standards for safety and efficacy in cardiovascular procedures.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK850652 | Date10 Apr 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- Withdrawn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
- Full name
- Pacesetter Systems, Endocardial Firm Lead
- 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
Is this lead designed for single-use or can it be reused in multiple patients?
This lead is explicitly labeled as a reusable medical device, meaning it is intended for use across multiple patients after proper cleaning, sterilization, and maintenance. Since it is classified under FDA 510(k) clearance (K850652) and governed by regulation 870.3620, it must adhere to strict reprocessing protocols to ensure safety and functionality for repeated cardiovascular applications.
What types of heart conditions or procedures is this lead intended to support?
The Endocardial Firm Lead is designed for endocardial placement within cardiac pacing systems to deliver electrical stimulation to the heart muscle. It is specifically intended for patients requiring pacing therapy to regulate heart rhythm, such as those with bradycardia or conduction system disorders. It is not intended for any other therapeutic or diagnostic purposes beyond its role in pacing systems.
How is this lead supplied, and what should clinicians consider when handling or storing it?
While the exact packaging details are not specified, as a reusable device, this lead must be sterilized and maintained per manufacturer guidelines before each use. Clinicians should store it in a clean, dry environment, protected from contamination, and follow reprocessing protocols to ensure sterility and functionality. Since it is governed by FDA regulations, adherence to reprocessing standards is critical for patient safety.
What regulatory pathway was followed for this device’s approval, and which committee reviewed it?
This lead was cleared through the FDA’s 510(k) process under the Cardiovascular (CV) Advisory Committee, with a decision of Substantially Equivalent (SESE) to a predicate device. The clearance (K850652) was granted in 1985, and it falls under product code DTD (Pacemaker Lead Adaptor). The review was conducted under traditional clearance procedures, meaning it was evaluated for safety and effectiveness in cardiovascular applications.