Opus Models 4033 and 4034 Implantable Pacemaker Pulse-Generator

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

Full name

Opus Models 4033 and 4034

510(k) Number

K894267 ↗

FDA Product Code

DXY

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. →

• Are the Opus Models 4033 and 4034 pacemakers designed for reuse or single-use, and how should they be handled to maintain sterility?

  The Opus Models 4033 and 4034 are sterile and intended for single-use only after implantation. Since they are sterile upon delivery, proper sterile medical device protocols must be followed during storage and handling to prevent contamination. This includes maintaining sealed packaging until immediate use and adhering to manufacturer guidelines for sterile field preparation during implantation.

• What programming frequency and MRI compatibility should clinicians consider when using these devices?

  These pacemakers operate at 50 MHz, but their MRI compatibility is not explicitly specified in the device data. Clinicians should refer to the user manual for any MRI-related restrictions or guidelines, as the device is labeled as *MRI-unspecified* unless otherwise noted. Always verify compatibility with the specific MRI system and protocol before exposing the patient.

• What storage conditions are required for the Opus Models 4033 and 4034 to ensure they remain effective?

  While the data does not specify exact storage conditions, since these are sterile, single-use implantable devices, they must be stored in accordance with sterile medical device protocols. This typically includes keeping them in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until ready for use.

• How do I determine if a specific lot of these devices has FDA clearance, and what does that mean for my purchase?

  Each lot of Opus Models 4033 and 4034 is regulated under FDA 510(k) clearance (K894267) and classified as a Class 3 Cardiovascular device. To verify clearance for a specific lot, check the registration number (e.g., 2017865, 3005334138, etc.) listed on the packaging or documentation. This clearance means the device meets FDA standards for safety and effectiveness as an implantable pacemaker pulse-generator, but it does not imply any specific clinical indication beyond what’s stated in the description.