Implant Elect Lead Mod 30-404 Using Polyu 90 a

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

510(k) Number

K852710 ↗

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 30-404 USING POLYU 90 A, and how does it function in the body?

  The IMPLANT ELECT LEAD MOD 30-404 is designed for implantation within the cardiovascular system to deliver electrical stimulation for pacing. It ensures proper heart rhythm and function in patients who require cardiac pacing support, helping regulate irregular heartbeats by delivering timed electrical impulses to the heart muscle.

• Is this device intended for reuse, or is it meant to be used only once after opening?

  This device is explicitly intended for single-use only. It is supplied sterile, meaning it should not be reused after implantation or even after initial handling, as reuse could compromise sterility and patient safety.

• What material is the lead constructed from, and does this affect its compatibility with MRI environments?

  The lead is constructed from polyurethane (Polyurethane 90A), a durable material chosen for its flexibility and biocompatibility. While it is designed for use in MRI environments, specific safety considerations must be followed—such as adhering to MRI facility protocols—to ensure safe imaging without interference or risk to the patient.

• How should this device be stored, and what precautions should be taken to maintain its sterility?

  The device must be stored and handled according to sterile medical device protocols to preserve its sterility. This includes keeping it in its original packaging until immediately before use, avoiding contamination, and following manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Never open or handle the lead unless ready for immediate implantation.

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

  This device was authorized through the FDA 510(k) clearance process, specifically under the Traditional pathway, with a decision described as *Substantially Equivalent*. The review was conducted by the Cardiovascular (CV) Advisory Committee, reflecting its classification as a Class III medical device under FDA regulations for permanent pacemaker electrodes.