Poly Flex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K802294 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

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  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  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 Poly Flex Implantable Pacing Lead designed to treat in patients, and how does it work?

  The Poly Flex Implantable Pacing Lead is designed to deliver electrical stimulation to the heart for patients requiring cardiac pacing. It helps regulate abnormal heart rhythms by providing implanted pacing signals, ensuring proper cardiac function when the heart’s natural rhythm is compromised.

• Is the Poly Flex Implantable Pacing Lead intended for reuse, or is it meant for single-use only?

  The Poly Flex Implantable Pacing Lead is explicitly intended for single-use implantation within the cardiovascular system. It is supplied sterile, and reuse is not recommended to maintain safety and efficacy.

• How should the Poly Flex Implantable Pacing Lead be stored before use, and why?

  The device must be stored and handled according to sterile medical device protocols to preserve its integrity before use. This ensures it remains uncontaminated and ready for implantation without compromising patient safety.

• What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its use?

  The Poly Flex Implantable Pacing Lead received FDA 510(k) clearance (K802294) through a traditional review process, with a decision of substantial equivalence to a predicate device. This means it was determined to have the same intended use and technological characteristics as a previously cleared device, ensuring compliance with FDA standards for safety and effectiveness.