Series (T) Programmable Cardiac Pulse Generators

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

510(k) Number

K861559 ↗

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. →

• Are these pacemaker pulse generators designed for reuse in multiple patients, or are they intended as single-use devices?

  The Series (T) Programmable Cardiac Pulse Generators are explicitly supplied as single-use, implantable devices. This means each unit is intended for one-time implantation in a single patient and should not be reused.

• What types of storage conditions should be followed for these devices before implantation?

  The provided data does not specify storage conditions, but as implantable devices, they should generally be stored in a clean, dry environment, protected from physical damage and extreme temperatures. Always refer to the manufacturer’s instructions for precise storage guidelines.

• What is the regulatory pathway for these devices, and how were they classified by the FDA?

  The Series (T) Programmable Cardiac Pulse Generators were cleared through the FDA’s 510(k) pathway (traditional review) under clearance number K861559. They are classified as Class III devices, indicating high-risk status, and fall under product code DXY with regulatory classification 870.3610. This classification reflects their critical role in treating life-sustaining cardiac conduction disorders.

• Are there multiple models or sizes available within this Series (T) Programmable Cardiac Pulse Generator line?

  The data lists multiple FEI numbers (e.g., 3002807576, 2017865) associated with the Series (T) devices, which typically correspond to different models or variants. While exact specifications like battery capacity or programming features aren’t detailed here, these identifiers suggest variability in the lineup. For precise sizing or model details, consult the manufacturer’s documentation or catalog.