Implant Elect Lead, Mod 030-405 Using Polyu 90 a

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

510(k) Number

K852708 ↗

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 primary purpose of the IMPLANT ELECT LEAD, MOD 030-405, and how does it function in the body?

  The IMPLANT ELECT LEAD, MOD 030-405, is designed as a permanent pacemaker electrode to deliver electrical impulses to the heart. It connects an external pacemaker generator to heart tissue, ensuring proper electrical conduction and maintaining a regular heartbeat for patients with bradycardia or conduction disorders. The lead transmits pacing signals to stimulate the heart muscle when its natural rhythm is too slow or irregular.

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

  This device is explicitly supplied as a single-use, sterile lead. It is intended for surgical implantation and should not be reused, as reuse could compromise sterility and patient safety. The polyurethane 90A construction is optimized for long-term cardiac applications, but the device is not designed for repeated use.

• What materials is the lead constructed from, and why is this important for its use?

  The lead is constructed using polyurethane 90A, a durable and biocompatible material chosen for its suitability in long-term cardiac applications. Polyurethane 90A provides flexibility, strength, and resistance to degradation, ensuring reliable performance over extended periods while minimizing the risk of adverse reactions or failure in the body.

• How is this device regulated, and what does the FDA clearance indicate about its safety and effectiveness?

  This device received FDA 510(k) clearance through a traditional review pathway, meaning it was determined to be substantially equivalent to a legally marketed predicate device. The clearance indicates that the FDA has reviewed its design, manufacturing processes, and clinical rationale, confirming that it meets applicable safety and performance standards for use as a permanent pacemaker electrode. The classification as a Class III device reflects its critical role in cardiac rhythm management.

• What should clinicians consider when storing or handling this lead before implantation?

  Since the lead is supplied sterile and intended for single-use, clinicians must ensure it remains unopened and uncontaminated until use. Storage should follow manufacturer guidelines to preserve sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures. The lead’s sterile packaging should not be compromised prior to surgical implantation to maintain its integrity and prevent infection.