Pacemaker Lead Adapter

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

510(k) Number

K890018 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• What is the Pacemaker Lead Adapter used for in a cardiac pacemaker system?

  The Pacemaker Lead Adapter connects a pacemaker lead to an implantable pulse generator, ensuring reliable electrical conduction between the two components while maintaining mechanical stability inside the cardiovascular system. It is specifically designed to improve the performance of cardiac pacemaker systems by facilitating this critical connection.

• Is the Pacemaker Lead Adapter intended for single-use or reusable in clinical settings?

  The Pacemaker Lead Adapter is explicitly designed for single-use in sterile conditions, as stated in its FDA 510(k) clearance documentation. This ensures patient safety and reduces the risk of contamination or device failure from repeated use.

• How should the Pacemaker Lead Adapter be stored to maintain its sterility and integrity?

  Since it is a sterile medical device, the Pacemaker Lead Adapter must be stored and handled according to standard sterile medical device protocols. This includes keeping it in its original packaging until immediate use and avoiding exposure to moisture, heat, or contamination to preserve its sterility and functionality.

• Are there any specific MRI safety considerations for this device?

  The device documentation does not specify any MRI safety restrictions, meaning it is not explicitly labeled as MRI-safe or MRI-conditional. However, clinicians should always verify compatibility with their specific MRI system and protocols before use, as individual facility policies may vary.

• What regulatory pathway was followed for FDA clearance of this device?

  The Pacemaker Lead Adapter received FDA clearance through a Traditional 510(k) pathway, classified under Class III (DTB) with a decision of *Substantially Equivalent* (SESE). The review was conducted by the Cardiovascular (CV) Advisory Committee, ensuring compliance with stringent safety and performance standards for permanent pacemaker electrodes.