Perm. Inplant Endocard. Pac. Lead
by Daig Corp. 510(k)
Active
510(k) K800347
Overview
This device is a Permanent Pacemaker Electrode, classified as a Class III medical device under FDA regulations. It is designed for endocardial implantation to provide electrical stimulation to the heart, facilitating pacing therapy for patients with bradycardia or other cardiac conduction disorders. The lead delivers timed electrical impulses to regulate heart rhythm, ensuring proper cardiac function in patients requiring chronic pacing support.
The Permanent Implant Endocardial Pacemaker Lead is intended for surgical implantation within the heart’s endocardial tissue, typically via a venous approach. It is supplied sterile and intended for single-use implantation, though the pacemaker itself may be reusable. The device must be implanted in a controlled clinical setting, such as a cardiac catheterization lab or operating room, by trained medical professionals. Compliance with FDA 510(k) clearance (K800347) ensures adherence to regulatory standards for permanent cardiac pacing leads, with no specific MRI safety restrictions noted in the available data.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK800347 | Date28 May 1980 | 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- Withdrawn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
- DTB
- Device Class
- Class III
- Regulation
- 21 CFR Part 870.3680
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Daig Corp.
Questions
What is the primary purpose of this Daig Corp. endocardial pacemaker lead, and how is it implanted?
This device is designed to provide chronic electrical stimulation to the heart’s endocardial tissue, specifically for patients with bradycardia or cardiac conduction disorders requiring pacing therapy. It is implanted surgically via a venous approach in a controlled setting like a cardiac catheterization lab or operating room by trained medical professionals. The lead delivers timed electrical impulses to regulate heart rhythm.
Is this pacemaker lead intended for single-use or reusable applications, and what does that mean for the device’s sterility?
The lead is supplied sterile and intended for single-use implantation, meaning each lead is meant to be used once during a patient’s procedure. While the lead itself is single-use, the pacemaker device itself may be reusable. Sterility ensures safe, contamination-free use during the critical implantation process.
What regulatory pathway does this device follow, and how does that affect its use in clinical practice?
This device follows the FDA 510(k) clearance pathway (K800347) under Class III classification, meaning it has undergone rigorous review to demonstrate substantial equivalence to a predicate device. Clinically, this ensures compliance with FDA standards for permanent cardiac pacing leads, though no specific MRI safety restrictions are noted in the available data.
Are there different sizes or models of this lead, and how would a clinician determine the appropriate one for a patient?
The provided data lists multiple FEI (Final Establishment Identification) numbers, which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, the device is designed for endocardial implantation, and sizing would be determined by the clinician based on patient anatomy, pacing requirements, and the specific surgical approach. Daig Corp. would provide detailed sizing guidance in their technical documentation.