Permanent Endocard. Unipolar Tined Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812905 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Disposable Patient Cable

  Class II

  FDA 510(k) K910645 Active Cleared 7 May 1991

• Cardiovascular Temp. Pacemaker Elec

  Class II

  FDA 510(k) K820003 Active Cleared 26 Mar 1982

• Endocard Pacing Lead Long Length PL200

  Class III

  FDA 510(k) K800349 Active Cleared 28 May 1980

• Permanent Endocardial Unipolar Tined Atrial Electrode

  Class III

  FDA 510(k) K812270 Active Cleared 16 Sep 1981

• Endocardial Screw-In Lead with Platinum Porous Tip

  Class III

  FDA 510(k) K852446 Active Cleared 17 Sep 1985

• Permanent & Temporary Pacemaker Electrode

  Class III

  FDA 510(k) K820262 Active Cleared 12 Mar 1982

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• What is the primary purpose of this unipolar tined lead, and how does its design support its function?

  This device is designed for permanent implantation within the endocardium to provide cardiac pacing for patients with atrial arrhythmias or bradycardia. The unipolar configuration ensures stable electrical contact, while the tines enhance fixation, helping to secure the lead in place for long-term reliability.

• Is this lead reusable, and if not, what precautions should be taken during handling and storage?

  The lead is explicitly intended for single-use only and is supplied in a sterile package. It must not be reused, as reuse could compromise sterility and patient safety. Store in a clean, dry environment away from direct sunlight or extreme temperatures, following the manufacturer’s guidelines to maintain sterility until implantation.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use in clinical settings?

  This lead received FDA 510(k) clearance (K812905) under the Cardiovascular advisory committee, classified as substantially equivalent to prior devices. This means it meets FDA standards for safety and effectiveness as a Permanent Pacemaker Electrode (DTB) and is regulated under 21 CFR 870.3680. Clinicians must ensure proper surgical placement by trained personnel in cardiac electrophysiology settings, adhering to FDA-compliant protocols.

• Are there any known limitations regarding compatibility with MRI machines, and what should clinicians consider?

  The device data does not specify MRI safety data, meaning its compatibility with MRI machines is not confirmed. Clinicians should exercise extreme caution when considering MRI for patients with this lead, as untested exposure could pose risks to both the patient and the imaging equipment. Always consult the manufacturer’s guidelines or a cardiologist before proceeding.

• What types of patients is this lead intended for, and what clinical conditions does it address?

  This lead is intended for patients requiring permanent cardiac pacing due to atrial arrhythmias or bradycardia, where stable endocardial fixation is critical. It is not indicated for temporary use or other arrhythmia types—only for long-term rhythm management in patients with chronic pacing needs, as determined by a clinician.