Model RZ Pacemaker Lead
by Dr. Ing. P. Osypka, GmbH 510(k)
Active
510(k) K823894
Overview
The Model RZ Pacemaker Lead is a Permanent Pacemaker Electrode, designed for implantation in the cardiovascular system to deliver electrical stimulation to the heart. It facilitates pacing therapy by transmitting electrical impulses to regulate abnormal heart rhythms, ensuring proper cardiac function in patients requiring chronic pacing support.
This device is supplied as a reusable, sterile medical implant intended for use in clinical settings by trained healthcare professionals. It is classified under FDA regulation 870.3680 and falls under the DTB product code, with clearance granted as Substantially Equivalent (SESE) via a Traditional 510(k) pathway. Multiple reference codes (e.g., 3002618605, 1028232) identify variations of this lead, all adhering to Class III medical device standards.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK823894 | Date30 Apr 1983 | 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- Withdrawn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
- Full name
- Model Rz Pacemaker Lead Various
- 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 Dr. Ing. P. Osypka, GmbH
Questions
What is the primary purpose of the Model RZ Pacemaker Lead, and how does it function in the body?
The Model RZ Pacemaker Lead is designed as a permanent pacemaker electrode for implantation in the cardiovascular system. It delivers electrical stimulation to the heart to regulate abnormal heart rhythms, ensuring proper cardiac function in patients who require chronic pacing support. By transmitting controlled impulses, it helps maintain a steady heart rate and rhythm, particularly for those with conditions like bradycardia or heart block.
Is this device intended for single-use or can it be reused? How does sterility factor into its use?
The Model RZ Pacemaker Lead is reusable and supplied in a sterile condition for clinical use. Since it is implanted permanently, it must be handled under sterile conditions during implantation by trained healthcare professionals to prevent infection. The lead is not designed for repeated use in multiple patients but is intended to remain in place long-term within a single patient.
What regulatory pathway was followed for FDA clearance, and what does the classification mean for its use?
The Model RZ Pacemaker Lead received FDA clearance via a Traditional 510(k) pathway under the Substantially Equivalent (SESE) determination. This means the device was compared to a legally marketed predicate and found to have the same intended use and technological characteristics. It is classified as a Class III medical device, which requires pre-market approval due to its high-risk nature as a permanent implant. The clearance ensures it meets FDA safety and effectiveness standards for cardiovascular use.
Are there multiple variations of this lead, and how can I identify the correct model for my patient?
Yes, the Model RZ Pacemaker Lead comes in multiple variations, each identified by unique FEI numbers (e.g., 3002618605, 1028232, etc.). These variations may differ in specifications like lead length, electrode configuration, or pacing capabilities. To select the correct model, consult the manufacturer’s documentation or a healthcare professional to match the patient’s clinical needs (e.g., atrial, ventricular, or biventricular pacing) with the appropriate lead characteristics.
How should the Model RZ Pacemaker Lead be stored before implantation, and what precautions should be taken?
The lead should be stored in its original sterile packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Since it is reusable but intended for single-patient implantation, ensure the packaging remains unopened and intact until use. Follow the manufacturer’s instructions for handling to maintain sterility and prevent contamination, as improper storage could compromise its safety for implantation.