Stockert Cardiac Pacing Electrodes

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K812049 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Stockert Compact System Version 2.0

  Class II

  FDA 510(k) K002118 Active Cleared 9 Aug 2000

• Interface Module Iddd

  Class I

  FDA 510(k) K992635 Active Cleared 20 Dec 1999

• Stockert S3 Double Head Pump Module

  Class II

  FDA 510(k) K955038 Active Cleared 21 Feb 1996

• S3 Cyclic Rpm Control

  Class II

  FDA 510(k) K971520 Active Cleared 10 Sep 1997

• Stockert A272 Series Pediatric Aortic Cannulae

  Class II

  FDA 510(k) K002273 Active Cleared 29 Jan 2001

• Stockert Compact System

  Class II

  FDA 510(k) K982014 Active Cleared 4 Sep 1998

See all devices from Stoeckert Instrumente →

• Are these pacing electrodes designed for reuse or are they intended for single-use only?

  The Stockert Cardiac Pacing Electrodes are explicitly supplied sterile and intended for single-use only. This aligns with standard medical device protocols for transvenous implantation to maintain patient safety and sterility during cardiovascular procedures.

• What types of heart conditions are these electrodes intended to address?

  These electrodes are designed to facilitate cardiac pacing by delivering low-energy electrical impulses to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent and reliable cardiac function.

• How are these electrodes regulated in the U.S., and what does that mean for purchasing or use?

  The Stockert Cardiac Pacing Electrodes are classified as a Class III device under FDA regulation (870.3680) and hold a 510(k) clearance (K812049). This means they are subject to rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for transvenous implantation in cardiovascular procedures.

• What reference codes or part numbers should I look for when ordering these electrodes?

  These electrodes are available under multiple reference codes, including (but not limited to): 3002618605, 1028232, 3008377825, and others listed in the FDA’s OpenFDA database. Always verify the specific code matches your procedure requirements, as variations may exist for different electrode designs or configurations.

• How should these electrodes be stored before use to maintain their sterility?

  Since these electrodes are supplied sterile, they must be stored in their original packaging until use, following standard medical device sterilization and handling protocols. Avoid exposure to moisture, extreme temperatures, or contamination to preserve sterility for a single-use procedure.