Implantable Programmable Bipolar Cardiac (K800573)

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

Full name

Implantable Programmable Bipolar Cardiac

510(k) Number

K800573 ↗

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

• 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

• Implantable Electrode Lead, Model 030-446

  Class III

  FDA 510(k) K874664 Active Cleared 31 May 1988

See all devices from Telectronics, Inc. →

• What is the primary purpose of this implantable device, and how does it function in the body?

  This device is an implantable pacemaker pulse-generator designed to replace the heart’s natural pacing functions in patients with bradycardia or conduction disorders. It delivers programmable electrical stimulation via bipolar leads to regulate heart rhythm, ensuring consistent contractions when the heart’s intrinsic electrical system fails.

• Is this device intended for reuse, or is it meant to be implanted as a single-use item?

  The device is sterile and supplied for single-use implantation only, meaning it is not designed for reuse. Once implanted, it remains in place as a permanent solution for the patient’s pacing needs.

• What regulatory pathway was followed for this device’s approval, and which advisory committee reviewed it?

  This device received FDA 510(k) clearance (K800573) under the Traditional 510(k) pathway, classified as substantially equivalent to a predicate device. The review was conducted by the FDA’s Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under regulation 870.3610.

• How is this device typically supplied, and what should clinicians consider during storage?

  The device is sterile-packaged for surgical implantation and comes pre-sterilized to ensure safety for direct patient use. Clinicians should store it in a clean, dry environment away from extreme temperatures or moisture, adhering to manufacturer guidelines for shelf life and handling to maintain sterility and functionality.