Opus Model 4001 Implantable Pacemaker Pulse-Generator

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

Full name

Opus Model 4001

510(k) Number

K894065 ↗

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 Opus Model 4001 used for in clinical practice?

  The Opus Model 4001 is an implantable pacemaker pulse-generator designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails. It is specifically intended for patients with bradycardia or conduction disorders, ensuring proper cardiac function by compensating for slow or irregular heartbeats.

• Is the Opus Model 4001 meant to be reused, or is it single-use only?

  The Opus Model 4001 is supplied as a single-use, non-reusable component. Due to its sterile implantation requirements, it must be handled under aseptic conditions and discarded after one use to maintain patient safety and device efficacy.

• How should the Opus Model 4001 be stored before implantation?

  The device must be stored according to the manufacturer’s guidelines, which likely include maintaining sterility and proper environmental conditions (e.g., temperature, humidity) to preserve its integrity until surgical implantation. Since it is non-reusable, storage should follow aseptic protocols to prevent contamination.

• What regulatory pathway was followed for FDA clearance of the Opus Model 4001?

  The Opus Model 4001 received FDA clearance through a 510(k) submission, classified as a Class III medical device under the Implantable Pacemaker Pulse-Generator category (product code DXY). The clearance was granted by the FDA’s Cardiovascular (CV) Advisory Committee under a Traditional 510(k) review, with a decision date of September 26, 1989, and a clearance number of K894065.

• Who is the manufacturer responsible for the Opus Model 4001, and where are they located?

  The manufacturer of the Opus Model 4001 is Ela Medical, Inc., headquartered at 15245 Minnetonka Blvd., Minnetonka, MN 55345, USA. For inquiries, contact information is available through the listed address or via the provided contact, Paul Kohl.