Resteril. of Implant. Elect. & Adapter

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

510(k) Number

K772331 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

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 resteril process for this implantable electrode and adapter intended to achieve, and how does it differ from a standard single-use device?

  The resteril process for this device is designed to allow reuse of the implantable electrode and adapter after undergoing strict medical device sterilization and reprocessing protocols. Unlike single-use devices, this system is engineered to be cleaned, sterilized, and reimplanted in accordance with FDA guidelines, ensuring safety and efficacy for repeated use in cardiovascular applications. This approach is particularly relevant in clinical settings where resource optimization is important.

• How is this device classified and what regulatory pathway was used for its FDA clearance?

  This device is classified as a Class 3 Cardiovascular product under FDA product code DTB, indicating it carries higher regulatory scrutiny due to its role in life-sustaining or life-supporting functions. It was cleared via the Traditional 510(k) pathway under FDA clearance K772331, originally reviewed in 1978, with a Substantially Equivalent (SESE) determination by the Cardiovascular (CV) Advisory Committee. This means it was deemed comparable to legally marketed devices of a similar type.

• Are there any specific storage or handling requirements for this resterilized device to ensure its safety and functionality?

  While the data does not specify exact storage conditions, the resteril process for this device must adhere to FDA reprocessing guidelines to maintain sterility and integrity. Proper handling—including cleaning, sterilization, and storage in a sterile environment—is critical to prevent contamination or degradation before reuse. Clinicians should follow manufacturer-provided instructions for resterilization protocols to ensure compliance with medical device safety standards.

• What types of patients or clinical scenarios is this device intended for, based on its design and regulatory classification?

  This device is designed for patients requiring permanent pacemaker therapy to regulate heart rhythm and support cardiac function. As a Class 3 Cardiovascular device, it is intended for use in regulated clinical settings where electrical stimulation of the heart is necessary, such as in bradycardia or conduction system disorders. The resteril process allows for reuse in controlled environments where multiple implantations may be required, such as research or specialized cardiac centers.