Polyflex Implantable Pacing Lead-476-07

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853521 ↗

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

  Class III

  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 Polyflex Implantable Pacing Lead 476-07 used for in clinical practice?

  The Polyflex Implantable Pacing Lead 476-07 is designed for transvenous implantation to deliver electrical stimulation to the heart, specifically targeting the right ventricle or atrium. It supports patients with bradycardia or conduction disorders by facilitating cardiac pacing during surgical procedures performed by trained healthcare professionals.

• Is this device intended for single-use or can it be reused?

  The Polyflex Implantable Pacing Lead 476-07 is explicitly supplied sterile and intended for single-use only. It must be handled under aseptic conditions to ensure sterility and functionality, as reuse is not supported by the manufacturer’s design or regulatory classification.

• How should this device be stored to maintain its integrity?

  Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. While specific conditions aren’t detailed here, the lead’s single-use nature and sterile packaging imply it should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures until immediate use.

• What regulatory pathway does this device follow, and which committee was involved?

  The Polyflex Implantable Pacing Lead 476-07 was cleared via the FDA 510(k) process under the Cardiovascular (CV) Advisory Committee, with a decision of *Substantially Equivalent* (SESE) in 1985. It falls under Device Class III, reflecting its critical role in life-sustaining or supporting functions.

• Are there multiple models or sizes available for this lead?

  The provided data does not specify varying sizes or models beyond the 476-07 designation, but the OpenFDA registration numbers suggest multiple lot/batch identifiers exist for manufacturing consistency. For exact sizing options (e.g., coil length, electrode placement), consult the manufacturer’s technical documentation or catalog.