Permanent Pacemaker Electrode Sterilization

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

Full name

Sterilization

510(k) Number

K943657 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• 100 cm Permanent Pacing Lead Models

  Class III

  FDA 510(k) K911273 Active Cleared 28 Aug 1991

• Pellethan Adhesive on Polyurethane Leads-MODI

  Class III

  FDA 510(k) K893041 Active Cleared 14 Nov 1989

• Optima MPT Model 5281E and Model 5282E

  Class III

  FDA 510(k) K897116 Active Cleared 14 Mar 1990

• Telectronics Pacing Systems Vs-1 to 6mm Upsizing

  Class II

  FDA 510(k) K895971 Active Cleared 22 Feb 1990

• Bifurcated Vs-1 to Vs-1 Lead Adaptor

  Class II

  FDA 510(k) K910112 Active Cleared 25 Feb 1991

• Vs-1 Lead Ext. 033-302, 4.75mm 033-260, 033-458

  Class III

  FDA 510(k) K901402 Active Cleared 12 Jun 1990

See all devices from Telectronics Pacing Systems, Inc. →

• What is the primary purpose of this sterilization process for pacemaker electrodes, and how does it relate to patient safety?

  This sterilization process ensures that permanent pacemaker electrodes meet strict regulatory standards for safe implantation. Since these electrodes are intended for single-use in sterile conditions within cardiovascular procedures, the process guarantees they are free from contamination before use, reducing infection risks for patients requiring cardiac rhythm management.

• Are these electrodes reusable, or are they designed for single-use only? How does this affect clinical workflow?

  These electrodes are explicitly designed for single-use only in sterile conditions, aligning with medical specialty standards for cardiovascular devices. This design eliminates the need for reprocessing, streamlining workflows by ensuring immediate readiness for implantation without sterilization between patients.

• What regulatory pathway was followed for FDA clearance, and why does it include ‘Subject to Tracking’?

  The device received FDA clearance under the Traditional 510(k) pathway (K943657) with a Substantially Equivalent decision classification. The ‘Subject to Tracking’ designation indicates the FDA requires additional monitoring due to the device’s classification as Class III (under regulation 870.3680), which includes higher-risk cardiovascular implants like permanent pacemaker electrodes.

• How does the sterilization process ensure compliance with FDA requirements for these electrodes?

  The sterilization process adheres to FDA’s 510(k) clearance criteria (K943657) and follows Traditional pathway standards, ensuring electrodes meet regulatory benchmarks for safety and efficacy. The process is validated to maintain sterility and integrity, critical for single-use implantation in cardiovascular procedures, as outlined in the Cardiovascular advisory committee review.