Model 329D, Seriers R Biopolar Cardiac Pul. Gen.

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

510(k) Number

K860466 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Cook Pacemaker Corp. →

• What is the primary purpose of the Model 329D Series R Bipolar Cardiac Pulse Generator and who should use it?

  The Model 329D is designed to provide electrical stimulation to regulate heart rhythm in patients with bradycardia or conduction disorders, ensuring consistent pacing. It is intended for surgical implantation by qualified healthcare professionals, specifically cardiologists or cardiac surgeons, in clinical settings where cardiac pacing is medically necessary.

• Is this device single-use or reusable, and how should it be handled to maintain sterility?

  The Model 329D is supplied sterile for single-use only. To maintain sterility, it must be handled using aseptic techniques, stored in its original packaging, and protected from contamination until implantation. Follow the manufacturer’s guidelines for proper storage and preparation to ensure functionality and safety.

• What safety considerations should clinicians be aware of when using this device, particularly regarding MRI?

  This device is not MRI-safe, meaning it should not be exposed to MRI environments. The presence of an implanted Model 329D could pose risks during MRI procedures, including potential damage to the device or interference with imaging. Always verify compatibility with MRI systems before any patient undergoes such scans.

• How is this device regulated, and what does the FDA’s classification mean for its use?

  The Model 329D is classified as a Class III device under FDA regulations, indicating it carries significant risk and requires pre-market approval or clearance. It was granted FDA 510(k) clearance (K860466) under the Traditional review pathway, meaning it was deemed substantially equivalent to a legally marketed predicate device. This clearance ensures it meets FDA standards for safety and effectiveness for its intended use in cardiac pacing.

• What storage conditions should be followed for the Model 329D to preserve its functionality?

  The device should be stored in its original, unopened packaging to protect it from moisture, dust, and physical damage. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Adhere to the manufacturer’s instructions for shelf life and storage to ensure reliability before implantation.