Intermedics Model 431-11 Implant Endocard Pac Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K903948 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

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  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

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  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• What is the primary purpose of the Intermedics Model 431-11 Implant Endocard Pac Lead, and where is it typically placed in the body?

  The Intermedics Model 431-11 is designed for chronic endocardial pacing, delivering electrical stimulation to the heart’s inner lining (endocardium) to manage bradycardia or conduction disorders. It is implanted via venous access and positioned within the right atrium or ventricle for long-term use.

• Is this device intended for single-use or reusable implantation, and how should it be stored?

  The Model 431-11 is supplied sterile and intended for single-use implantation only. Storage must follow manufacturer guidelines to maintain sterile packaging integrity, ensuring it remains uncontaminated before use.

• What regulatory pathway does this pacemaker lead follow, and which advisory committee oversees its classification?

  The device follows the FDA 510(k) clearance pathway (K903948) under Class III classification (DTB) for cardiovascular devices. Its regulatory oversight falls under the Cardiovascular (CV) Advisory Committee, reflecting its chronic use in the cardiovascular system.

• Does this lead have any special considerations for MRI compatibility, and how does that affect its use?

  Yes, the Model 431-11 is designed with MRI safety considerations for pacemaker leads in mind. This means it is engineered to minimize risks during MRI procedures, though specific protocols (e.g., field strength limits) should still be followed as per manufacturer instructions to ensure patient safety.