Opus Model 4021 VVI 5MM Unipolar

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

510(k) Number

K900461 ↗

FDA Product Code

DXY

Models / Variants

4021

Vvi

5mm Unipolar

Device Class

Class III

Regulation

21 CFR Part 870.3610

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 primary purpose of the Opus Model 4021 pacemaker, and how does it differ from other pacing modes?

  The Opus Model 4021 is designed to regulate cardiac rhythm in patients with bradycardia or conduction system disorders by delivering timed electrical impulses to the heart’s ventricles. It operates in ventricular-demand (VVI) mode, meaning it only activates when the heart’s natural rhythm falls below a preset rate, ensuring pacing impulses are delivered only when needed. This differs from other pacing modes (like atrial or dual-chamber) as it focuses solely on ventricular stimulation, avoiding unnecessary atrial pacing.

• Is the Opus Model 4021 intended for reuse, or is it meant to be implanted as a single-use device?

  The Opus Model 4021 is explicitly intended for single-use implantation only. It is supplied sterile and designed for surgical use in a controlled clinical setting, requiring proper handling and adherence to manufacturer guidelines to maintain sterility and safety during and after implantation.

• What electrode tip size does the Opus Model 4021 use, and how might this affect its clinical application?

  The device features a 5mm unipolar electrode tip, which is standard for ventricular pacing leads. This size balances stability and tissue compatibility, ensuring reliable electrical contact with the ventricular myocardium while minimizing trauma during implantation. The unipolar design simplifies lead placement and reduces complexity compared to bipolar leads.

• How should the Opus Model 4021 be stored, and are there any special considerations for its shelf life?

  The Opus Model 4021 must be stored sterile and in its original packaging until use, following the manufacturer’s guidelines to preserve integrity. While the data does not specify shelf life, all implantable devices require adherence to sterile storage conditions (e.g., controlled temperature, protection from moisture) to prevent contamination. Always verify the packaging seal and expiration date before use.

• Does the Opus Model 4021 have any specific MRI safety considerations post-implantation?

  Yes, the Opus Model 4021 adheres to MRI safety standards for post-implantation monitoring, though exact compatibility details (e.g., safe scan parameters) are not provided in the data. Patients implanted with this device should consult the manufacturer’s guidelines or their clinician to determine MRI safety protocols, as pacemakers may interact with magnetic fields. Always verify compatibility before MRI procedures.