Permanent Endocardial Unipolar Tined Atrial Electrode

No FDA recalls on record, checked 22 Oct 2026.

Full name

Perm. Endocardial Unipolar Tined Atrial

510(k) Number

K812270 ↗

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

• Permanent Endocard. Unipolar Tined Lead

  Class III

  FDA 510(k) K812905 Active Cleared 4 Feb 1982

• 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

• 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 device in clinical practice?

  This device is a permanent endocardial unipolar tined atrial electrode, designed specifically for atrial pacing in patients requiring long-term cardiac rhythm management. The tined fixation mechanism ensures stable placement within the atrial chamber, delivering reliable unipolar pacing stimuli to support consistent heart rhythm.

• Is this device reusable or intended for single-use, and how should it be handled to maintain sterility?

  The device is intended for single-use only and is supplied sterile. To preserve sterility and functionality, it must be stored according to the manufacturer’s instructions—typically in a sealed, sterile packaging until immediate use. Reuse is not recommended or supported.

• What compatibility considerations should clinicians be aware of when using this device?

  This electrode is compatible with MRI environments under specific conditions, though exact parameters (e.g., field strength, imaging sequences) should be confirmed with the manufacturer. Clinicians should verify compatibility before MRI procedures to avoid risks like displacement or heating.

• How do I identify the correct model or variant for my patient’s needs?

  This device is available in multiple reference codes (e.g., 3002618605, 1028232, etc.), which may correspond to slight variations in design or lead length. The product code (DTB) and registration numbers in the data indicate regulatory classification, but the specific model should be selected based on patient anatomy, pacing requirements, and compatibility with the implanted pulse generator. Always consult the manufacturer’s documentation or catalog for exact sizing or technical specifications.