Slimline Unipolar Endocardial Pacing Lead, #30-407

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

510(k) Number

K853223 ↗

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 Slimline Unipolar Endocardial Pacing Lead (#30-407) in clinical practice?

  The Slimline Unipolar Endocardial Pacing Lead (#30-407) is designed to deliver electrical stimulation to the heart’s inner lining (endocardium) to regulate abnormal slow heart rhythms (bradycardia) or conduction disorders. Its unipolar configuration ensures consistent pacing support by positioning the electrode tip against the endocardium, typically via venous implantation during cardiac electrophysiology procedures.

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

  The Slimline Unipolar Endocardial Pacing Lead (#30-407) is supplied sterile and explicitly intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and device integrity.

• How should this device be stored to maintain its sterility and functionality?

  The manufacturer specifies that proper storage must adhere to their guidelines to preserve sterility and functionality. While exact storage conditions aren’t detailed, typical best practices for sterile medical devices—such as keeping the packaging sealed, avoiding contamination, and storing in a clean, dry environment—should be followed. Always refer to the manufacturer’s instructions for precise storage requirements.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The Slimline Unipolar Endocardial Pacing Lead (#30-407) was cleared under the traditional review pathway via an FDA 510(k) submission (K853223) and is classified as a Class III device under regulation number 870.3680. This classification reflects its role as a permanent pacemaker electrode, requiring stringent regulatory oversight.

• Does this device have any known compatibility with MRI procedures?

  The manufacturer does not specify MRI compatibility for the Slimline Unipolar Endocardial Pacing Lead (#30-407). Clinicians should exercise caution and consult the manufacturer’s guidelines or additional safety data before using this device in an MRI environment, as untested exposure could pose risks.