Implantable Programmable Cardiac Pulse

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

510(k) Number

K810603 ↗

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 what types of patients would benefit from it?

  This device is an Implantable Pacemaker Pulse-Generator designed to regulate heart rhythm by delivering electrical impulses when the heart’s natural pacemaker fails. It treats bradycardia (slow heart rate) and other cardiac conduction disorders, ensuring consistent contractions in patients whose hearts do not beat adequately on their own. Clinicians typically recommend it for patients with persistent slow heart rhythms or conduction blockages.

• Is this device intended for single-use or can it be reused after implantation?

  The device is explicitly designed for single-use after initial programming. Once implanted, it is not intended to be removed or reused, aligning with standard practice for pacemaker pulse-generators to avoid infection or reliability risks. Sterility is critical prior to implantation, as noted in the specifications.

• What storage or handling precautions must be taken before implantation?

  This device must be handled in sterile conditions before implantation, as sterility is a critical consideration per the manufacturer’s specifications. It should be stored according to the provided instructions to maintain its integrity and functionality until use, typically in a sealed, sterile packaging until opened for surgical preparation.

• How was this device’s regulatory pathway determined, and what does that mean for clinicians?

  The device was cleared via a Traditional 510(k) pathway (K810603) and classified as a Class III medical device under FDA regulations, with a substantially equivalent determination by the Cardiovascular (CV) Advisory Committee. Clinicians can rely on this clearance as evidence of safety and performance equivalence to a predicate device, ensuring it meets FDA standards for pacemaker pulse-generators.