Universal Terminal Cap, 3.2MM

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K913919 ↗

FDA Product Code

KFJ

Device Class

Class III

Regulation

21 CFR Part 870.3710

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 Universal Terminal Cap, 3.2mm used for in clinical settings?

  The Universal Terminal Cap, 3.2mm is designed as an adapter component for pacemaker leads, allowing clinicians to connect or modify lead terminals. Its purpose is to ensure compatibility with pacing systems, enabling proper electrical conduction in cardiovascular applications, particularly when lead repairs or modifications are required.

• Is this device single-use or reusable, and what does that mean for its handling?

  The Universal Terminal Cap, 3.2mm is explicitly labeled as a reusable component for pacemaker lead systems. Since it is not sterile, it must be handled under strict aseptic conditions before use, meaning it should be cleaned, inspected, and prepared according to manufacturer guidelines to maintain safety and functionality.

• How should I store this device to keep it in good condition?

  The device should be stored following the manufacturer’s guidelines to preserve its integrity. While specific storage instructions aren’t detailed here, general best practices for reusable medical components—such as keeping it in a clean, dry environment and protecting it from contamination—should be applied to avoid damage or degradation.

• What regulatory pathway was used for FDA clearance, and what does that mean for its classification?

  The Universal Terminal Cap, 3.2mm received FDA clearance through the Traditional 510(k) pathway under the classification of a Class III medical device. This means it was determined to be substantially equivalent to a legally marketed predicate device, though Class III classification indicates it carries higher regulatory scrutiny due to its role in life-supporting or sustaining functions.