Implantable Programmable Pulse Gener

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

510(k) Number

K840737 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Slimline Unipolar Endocardial Pacing Lead, 030-438

  Class III

  FDA 510(k) K865098 Active Cleared 18 Aug 1987

• Model 030-437 Implant Electrode

  Class III

  FDA 510(k) K870610 Active Cleared 20 Mar 1987

• Sterile Packaging

  Class III

  FDA 510(k) K810410 Active Cleared 5 Mar 1981

• Implantable Programmable Bipolar Cardiac (K800573)

  Class III

  FDA 510(k) K800573 Active Cleared 25 Mar 1980

• Laserpor Ap Atrial Endocard. Electr. Ld.

  Class III

  FDA 510(k) K820121 Active Cleared 12 Feb 1982

• Electrode, Model 030-324

  Class II

  FDA 510(k) K781822 Active Cleared 8 Feb 1979

See all devices from Telectronics, Inc. →

• What is the primary purpose of this implantable device, and who is it designed for?

  This device is an Implantable Pacemaker Pulse-Generator, designed to regulate abnormal heart rhythms (bradycardia or conduction disorders) by delivering programmable electrical impulses to the heart. It is intended for patients requiring chronic pacing support, allowing adjustments to pacing parameters tailored to individual patient needs.

• Is this device reusable, or is it meant for single-use after implantation?

  The device is intended for single-use implantation only, as explicitly stated in the regulatory data. It is supplied sterile and not designed for reuse.

• How is this device classified, and what regulatory pathway was followed for its approval?

  This is a Class III medical device under FDA regulations, reviewed by the Cardiovascular Advisory Committee and cleared via a Traditional 510(k) pathway (K840737). It falls under product code DXY and regulation 870.3610, with a decision of *Substantially Equivalent* (SESE).

• Does this device have any special handling requirements, such as storage or sterility considerations?

  The device is supplied sterile and must be handled under aseptic conditions prior to implantation. Since it is single-use, proper storage in a clean, dry environment (as per manufacturer guidelines) is recommended to maintain sterility until use.

• Are there any known limitations regarding compatibility with other medical procedures, such as MRI?

  The regulatory data does not specify MRI safety for this device, meaning its compatibility with MRI procedures is not confirmed or recommended. Patients should avoid MRI scans unless explicitly cleared by the device manufacturer or a cardiologist.