Multilith 3 Models 1350, 3350, 1370, 3370 - 1350

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

510(k) Number

K863898 ↗

FDA Product Code

DXY

Models / Variants

1350

3350

1370

3370

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 these pacemaker pulse-generators reusable or intended for single-use, and why does that matter in clinical settings?

  The Multilith 3 Models (1350, 3350, 1370, 3370) are explicitly designed for single-use implantation and supplied sterile. This is critical because implantable devices must adhere to strict aseptic protocols to prevent infection, and single-use models eliminate cross-contamination risks between patients. Reuse could compromise sterility and patient safety, so these devices are not intended for reprocessing.

• What distinguishes the different models (1350, 3350, 1370, 3370) from one another in terms of functionality?

  While the exact functional differences aren’t detailed in the data, the models are tailored for specific patient needs as noted in the description. Variations in programming and pacing capabilities likely differentiate them—for example, one model may prioritize temporary support, while another offers permanent pacing. Clinicians should consult the manufacturer’s documentation for precise model-specific features, such as pacing modes or battery longevity.

• How should these devices be stored before implantation, and what precautions should be taken?

  Since the Multilith 3 pulse-generators are sterile and single-use, they must be stored in their original packaging under aseptic conditions to maintain sterility. Exposure to moisture, contamination, or physical damage could compromise integrity. The manufacturer’s instructions should specify storage temperature and environmental controls, but generally, they should be kept in a clean, dry area away from direct sunlight or extreme temperatures until ready for use.

• What regulatory pathway was followed for FDA clearance, and how does that affect their use in clinical practice?

  The Multilith 3 models received FDA 510(k) clearance (K863898) under the Traditional 510(k) Review pathway, with a decision of *Substantially Equivalent* to a predicate device. This means the FDA determined they meet the same performance standards as an existing approved pacemaker pulse-generator. Clinically, this clearance ensures the device complies with 21 CFR 870.3610 and has undergone rigorous testing for safety and effectiveness, but practitioners should always verify compatibility with their institution’s protocols and patient-specific needs.