DF-1 Terminal Cap

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

510(k) Number

K954551 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

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See all devices from Pacesetter, Inc. →

• What is the DF-1 Terminal Cap used for in a clinical setting?

  The DF-1 Terminal Cap is a connector component designed specifically for cardiac pacing systems. It ensures reliable electrical continuity between the pacing lead and the pulse generator, which is critical for maintaining proper signal transmission during cardiac rhythm management procedures. This makes it essential for permanent pacemaker implants where consistent electrical performance is required.

• Is the DF-1 Terminal Cap intended for single-use or can it be reused?

  The DF-1 Terminal Cap is explicitly intended for single-use only. It is supplied sterile and must be handled under aseptic conditions before implantation to preserve sterility. Reuse is not recommended or supported by the manufacturer, as it could compromise reliability and patient safety.

• How should the DF-1 Terminal Cap be stored to maintain its integrity?

  Since the DF-1 Terminal Cap is supplied sterile and intended for single-use, it should be stored in its original packaging until ready for use. The packaging is designed to protect sterility, so it should remain unopened and undamaged. Proper storage conditions, such as avoiding extreme temperatures or contamination, are essential to ensure the device remains suitable for its intended clinical application.

• What regulatory pathway was followed for the DF-1 Terminal Cap’s FDA clearance?

  The DF-1 Terminal Cap was cleared through the traditional 510(k) pathway by the FDA, as it is classified as a Class III medical device under 21 CFR 870.3680. This pathway requires a demonstration of substantial equivalence to a predicate device, and the clearance was granted on December 26, 1995, with the K-number K954551. The device is also subject to tracking regulations, ensuring ongoing monitoring and compliance.