Cook Pacemaker Corp. 115 Unipolar Cardi

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

510(k) Number

K842081 ↗

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 Corp. 115 Unipolar Cardi device, and how does it differ from other pacemakers?

  The Cook Pacemaker Corp. 115 Unipolar Cardi is designed specifically as an implantable pulse-generator that regulates cardiac rhythm by delivering electrical impulses to the heart when natural contractions are insufficient. Unlike bipolar pacemakers, it uses a single electrode lead (unipolar system), which simplifies the lead configuration while still providing reliable pacing support for patients requiring temporary or permanent cardiac pacing.

• Is this device reusable, or is it intended for single-use only? How should it be handled before implantation?

  This device is non-reusable and must be used only once. It is supplied sterile and intended for surgical implantation by qualified healthcare professionals. To maintain sterility and functionality, it must be handled under sterile conditions prior to use, following the manufacturer’s storage guidelines closely.

• What regulatory pathway was followed for this device, and what does that mean for its use in clinical settings?

  The Cook Pacemaker Corp. 115 Unipolar Cardi was cleared through the FDA 510(k) process, specifically under the Traditional pathway with a substantially equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means it was deemed comparable to a legally marketed predicate device, ensuring it meets FDA safety and effectiveness standards for use in clinical settings as an implantable pacemaker pulse-generator.

• What storage conditions are recommended to preserve the device’s sterility and performance before use?

  While the exact storage conditions aren’t detailed here, the device is supplied sterile and must be stored according to the manufacturer’s guidelines to maintain both sterility and functionality. Typically, this includes protection from moisture, extreme temperatures, and physical damage until the time of implantation in a clinical setting.