Lifeline Endocardial Bipolar Lead 476-06

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853518 ↗

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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See all devices from Intermedics, Inc. →

• What is the primary purpose of the Lifeline Endocardial Bipolar Lead 476-06, and where is it typically implanted in the body?

  The Lifeline Endocardial Bipolar Lead 476-06 is designed for permanent pacemaker therapy, providing bipolar pacing and sensing capabilities to manage cardiac rhythm disorders. It is intended for endocardial placement, meaning it is inserted through venous access and positioned within the right atrium or right ventricle of the heart during implantation.

• Is this lead meant for single-use or can it be reused after implantation?

  This lead is explicitly intended for single-use implantation. It is supplied sterile and packaged for surgical use, so it should not be reused or reprocessed after implantation to ensure patient safety and device functionality.

• How should the lead be stored to maintain its sterility and functionality before use?

  The manufacturer specifies that proper storage must follow their guidelines to preserve sterility and functionality. Since it is supplied sterile and packaged for surgical use, it should be stored in its original packaging, away from moisture, extreme temperatures, and contamination until ready for implantation.

• What regulatory pathway was followed for FDA clearance of this device, and what class does it fall under?

  The Lifeline Endocardial Bipolar Lead 476-06 was cleared via the FDA 510(k) Traditional pathway and is classified as a Class III device under regulation 870.3680. This classification reflects its role in life-sustaining or supporting functions, requiring stringent regulatory oversight.