Modified J-Stiffener Wire Material in Lead Lines

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

510(k) Number

K897067 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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 the Modified J-Stiffener Wire Material in Lead Lines, and how does it improve pacemaker lead performance?

  The Modified J-Stiffener Wire Material is designed to enhance the structural integrity and positioning of pacemaker leads within the cardiovascular system. By reinforcing the lead lines, it helps maintain stable electrode placement, ensuring reliable pacing functionality during electrophysiology procedures.

• Is this device intended for single-use or can it be reused in multiple procedures?

  The Modified J-Stiffener Wire Material is explicitly described as a reusable component within pacemaker lead systems, meaning it is engineered for repeated use across multiple procedures.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its safety and equivalence?

  This device received FDA 510K clearance under the Traditional pathway, classified as substantially equivalent (SESE) to prior-generation devices. This means the FDA determined it has the same intended use and technological characteristics as legally marketed devices, ensuring it meets applicable safety and effectiveness requirements.

• Are there any specific storage requirements mentioned for this device?

  The provided data does not include explicit storage instructions for the Modified J-Stiffener Wire Material. Since it is a reusable component, proper handling and maintenance per manufacturer guidelines would be essential to ensure longevity and performance.

• What types of procedures is this device intended for, and what medical specialty does it fall under?

  This device is intended for use in electrophysiology procedures, specifically within the cardiovascular specialty. It is integrated into pacemaker lead systems to support reliable pacing functionality, which is critical in procedures involving heart rhythm management.