Pacemaker, Model DDP Electronic Circuit

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

510(k) Number

K782146 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

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See all devices from Arco Medical Products Co. →

• What types of heart conditions is this pacemaker designed to address, and how does it work?

  This pacemaker, Model DDP Electronic Circuit, is specifically designed to regulate heart rhythm for patients with bradycardia or other cardiac conduction disorders that require artificial pacing. It achieves this by delivering controlled electrical impulses to the heart muscle, helping to maintain a proper heartbeat when the natural conduction system is insufficient.

• Is this device intended for reuse, or is it meant to be implanted once and discarded?

  The Model DDP Electronic Circuit is supplied sterile and intended for single-use implantation only. After use, it should not be reused, as this could compromise patient safety and device performance. It must be handled according to standard sterile surgical procedures during implantation.

• What storage or handling precautions should be taken before implantation?

  Since this pacemaker is supplied sterile, it must be stored in its original packaging until ready for use to maintain sterility. The device should be handled using aseptic techniques, as it is intended for direct implantation by qualified medical professionals. Avoid exposure to moisture, contamination, or physical damage prior to use.

• Can this pacemaker be used in patients who require MRI procedures, or are there specific restrictions?

  The Model DDP Electronic Circuit is labeled as MRI-unspecified, meaning its compatibility with MRI procedures is not explicitly defined. Clinicians should consult the manufacturer’s guidelines and follow strict protocols to ensure patient safety if MRI is required, as improper handling could pose risks to both the patient and the device.

• What regulatory pathway was followed for this device’s approval, and what does that mean for clinicians?

  This pacemaker received FDA 510(k) clearance (K782146) under the Traditional review pathway, with the Cardiovascular (CV) Advisory Committee providing oversight. This means the device was deemed substantially equivalent to a legally marketed predicate device and is classified as a Class III medical device under FDA regulation 870.3610. Clinicians can rely on this approval as evidence of the device’s safety and effectiveness for its intended use, though ongoing postmarket surveillance applies.