Ela Medical Cardiac Pacemakers Multil 2 #1251 & 2251

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

510(k) Number

K853017 ↗

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. →

• What is the primary purpose of the ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 and who would benefit from it?

  The ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle. It is intended for patients with bradycardia (slow heart rate) or conduction disorders requiring chronic cardiac pacing, ensuring consistent stimulation to maintain a normal heart rate and rhythm. Clinicians would recommend this device for patients whose natural pacemaker is not functioning properly, helping them avoid symptoms like fatigue, dizziness, or fainting.

• How is the ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 supplied and what considerations should be taken during its use?

  The device is supplied as a reusable, implantable system intended for surgical placement by qualified healthcare professionals. It must be used in a sterile operating environment, adhering to standard sterile medical device protocols. Since it is implanted, proper aseptic techniques during surgery and sterile handling post-implantation are critical to prevent infection.

• What regulatory pathway does the ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 follow, and what does this mean for its use?

  The device follows the FDA 510(k) clearance pathway, specifically with the clearance number K853017, and is classified as a Class III medical device under the Implantable Pacemaker Pulse-Generator category (DXY). This means it has undergone a thorough review by the FDA’s Cardiovascular (CV) Advisory Committee to ensure safety and effectiveness. Clinicians can rely on this regulatory clearance to confirm the device meets established standards for chronic cardiac pacing.

• Are there any special handling or storage requirements for the ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 before implantation?

  While the device is reusable and intended for surgical implantation, its sterile handling and storage must comply with standard protocols for implantable medical devices. Since it is implanted directly into the body, it must be kept in a clean, controlled environment before use to prevent contamination. The manufacturer’s instructions should be followed for proper storage and preparation to ensure sterility and functionality.

• What types of patients or clinical scenarios would this device be most relevant for?

  This device is most relevant for patients diagnosed with chronic bradycardia or conduction disorders where the heart’s natural pacemaker is insufficient. It is particularly useful in scenarios where patients experience persistent slow heart rates, atrioventricular block, or other rhythm disturbances that require consistent electrical stimulation. Clinicians would consider it for patients who have not responded adequately to non-invasive treatments and require long-term pacing support.