Polyurethane Tubing for Permanent Pacemaker Electrode

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

Full name

New Extrusion Vendor for Polyurethane Tubing

510(k) Number

K914489 ↗

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 this polyurethane tubing in cardiac pacing systems?

  This polyurethane tubing serves as an insulating and protective layer for electrical leads in permanent pacemaker systems. Its design ensures durability and flexibility, which are critical for long-term implantation within the body while maintaining electrical isolation and structural integrity of the lead.

• Is this tubing intended for direct patient implantation, or is it used in manufacturing?

  The tubing is not intended for direct patient implantation. Instead, it is supplied as a reusable component in the manufacturing process of pacemaker electrodes, ensuring the leads meet quality and safety standards for later use in patients.

• How is this device regulated, and what committee oversees its submissions?

  This device is regulated under 21 CFR 870.3680 as a Class III medical device, with submissions reviewed by the Cardiovascular (CV) Advisory Committee. It holds an FDA 510(k) clearance (K914489) and was determined substantially equivalent through a traditional review process.

• Are there any specific storage or handling requirements mentioned for this tubing?

  The provided data does not specify storage or handling instructions for the tubing itself. However, as a reusable manufacturing component for pacemaker electrodes, it should be stored and handled in accordance with Telectronics Pacing Systems’ internal quality control protocols to maintain compliance and integrity.