Model 1740 Personal Pocket Programmer

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

510(k) Number

K864712 ↗

FDA Product Code

KRG

Device Class

Class III

Regulation

21 CFR Part 870.3700

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 clinical settings is the Model 1740 Personal Pocket Programmer designed to be used in, and how does it support cardiac rhythm management?

  The Model 1740 is a handheld device intended for use in controlled clinical environments, such as hospitals, electrophysiology labs, or outpatient cardiac clinics. It enables precise programming and configuration of implantable pacemakers and related cardiovascular devices, allowing clinicians to adjust pacing parameters and retrieve diagnostic data. This ensures accurate control over cardiac rhythm management systems, which is critical for patient care in settings where real-time device adjustments are necessary.

• Is the Model 1740 Personal Pocket Programmer intended for single-use or reusable applications, and what does this mean for maintenance?

  The device is explicitly designed for single-use or reusable programming of pacemakers and associated cardiovascular implants. This flexibility means facilities can choose whether to dispose of the unit after a single use or clean and reuse it, depending on their infection control protocols and operational workflows. Reuse would require adherence to manufacturer guidelines for disinfection and maintenance to ensure safety and functionality.

• What regulatory pathway was followed for FDA clearance of the Model 1740, and what does this imply about its compliance standards?

  The Model 1740 received FDA clearance under the traditional 510(k) review pathway (K864712), classified as substantially equivalent to a predicate device. This implies the device meets FDA’s regulatory requirements for cardiovascular device programming, including compliance with 21 CFR 870.3700, which governs pacemaker programmers. The clearance was granted by the Cardiovascular (CV) Advisory Committee, ensuring it adheres to rigorous standards for safety and effectiveness in programming implantable cardiac devices.

• Does the Model 1740 come with any specific sterility or MRI safety information, and what should clinicians consider when using it?

  The provided specifications do not include explicit details about sterility or MRI safety for the Model 1740. Clinicians should follow standard infection control practices when handling the device, particularly if reused, and consult manufacturer guidelines or device documentation for any additional precautions. For MRI environments, it’s critical to verify compatibility with the specific pacemaker or implant being programmed, as the programmer itself may not be MRI-safe but is designed to interface with MRI-compatible devices.