Cook Pacemaker 215 Unipolar Cardiac Implantable Pulse-Generator

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

Full name

Cook Pacemaker 215 Unipolar Cardiac-

510(k) Number

K841928 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Needle's Eye Snare

  Class II

  FDA 510(k) K961992 Active Cleared 27 Dec 1996

• Model P In-Line Bipolar Endocardial Tined Lead

  Class III

  FDA 510(k) K915188 Active Cleared 11 Sep 1992

• Cook Pacemaker Corp. 327T Series R Unipolar Cardi

  Class III

  FDA 510(k) K853590 Active Cleared 23 Oct 1985

• Model F Unipolar Endocardial Lead

  Class III

  FDA 510(k) K832255 Active Cleared 12 Aug 1983

• Model 325D Unipolar Cardiac Pulse Gen

  Class III

  FDA 510(k) K822904 Active Cleared 15 Oct 1982

• Model 329T Programmable, Bipolar Cardi

  Class III

  FDA 510(k) K832893 Active Cleared 4 Oct 1983

See all devices from Cook Pacemaker Corp. →

• What is the primary purpose of the Cook Pacemaker 215 Unipolar Cardiac Implantable Pulse-Generator, and how does it function in the body?

  The Cook Pacemaker 215 Unipolar Cardiac Implantable Pulse-Generator is designed to regulate heart rhythm by delivering electrical impulses to the heart muscle when the natural pacemaker fails. It provides temporary or permanent pacing support to ensure consistent cardiac output, helping patients with cardiac arrhythmias maintain a stable heartbeat.

• Is this device intended for single-use or can it be reused after implantation?

  The Cook Pacemaker 215 Unipolar is intended for single-use implantation, though the pulse-generator itself may be reusable in certain configurations. This means the system components used during surgery are typically disposed of after use, while the implanted pulse-generator may remain functional for extended periods under proper conditions.

• How is the device supplied, and what precautions should be taken during handling?

  The device is supplied as a sterile, pre-packaged system, ensuring it is ready for use in a sterile surgical setting. Proper handling and storage are critical to maintain sterility and functionality, following the manufacturer’s guidelines to avoid contamination or damage before implantation.

• Can this device be used in patients who require MRI scans, and why?

  No, the Cook Pacemaker 215 Unipolar is not MRI-safe. It must be used with extreme caution in environments where magnetic resonance imaging is performed, as MRI machines generate strong magnetic fields that could interfere with the device’s operation or cause harm to the patient.

• What regulatory pathway does this device follow, and how is it classified?

  The Cook Pacemaker 215 Unipolar is classified as a Class III medical device under FDA regulations, requiring pre-market approval due to its critical role in managing life-threatening cardiac conditions. It holds FDA 510(k) clearance under product code DXY and is regulated under 21 CFR 870.3610 for implantable cardiac devices, with a decision of *Substantially Equivalent* by the Cardiovascular Advisory Committee.