Model 431-06 Polyflex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864002 ↗

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. →

• Is the Model 431-06 Polyflex Implantable Pacing Lead designed for reuse or single-use, and how does this affect its sterility?

  The Model 431-06 Polyflex Implantable Pacing Lead is explicitly intended for single-use implantation, as stated in the device description. Since it is supplied sterile, this ensures it meets the necessary infection control standards for direct cardiac placement without risking contamination from repeated use.

• What types of heart chambers is this pacing lead compatible with, and how does its flexibility factor into its design?

  The lead is described as flexible, which suggests it is designed to accommodate various heart chambers (e.g., atrium, ventricle, or both) while minimizing trauma during implantation. Its flexibility allows for easier navigation through the vascular system and positioning within the heart, improving compatibility with different pacing systems.

• How is this device regulated, and what does the FDA’s 510(k) clearance (K864002) indicate about its safety and equivalence?

  The Model 431-06 received FDA 510(k) clearance under the Traditional Review pathway, with a decision date of November 20, 1986. The clearance type is labeled as Substantially Equivalent (SESE), meaning the FDA determined it is as safe and effective as a legally marketed predicate device. This classification confirms it meets regulatory standards for cardiovascular devices and is approved for use in treating bradycardia or conduction disorders.

• Where is this device manufactured and distributed, and how can I verify its authenticity?

  The device is manufactured by Intermedics, Inc. and distributed from their headquarters at P.O. Box 617, Freeport, TX 77541. To verify authenticity, check the FEI numbers (e.g., 2017865, 3002618605) listed in the OpenFDA database or contact Intermedics directly via their provided contact (KEN BISHOP). These identifiers help confirm the device’s regulatory compliance and traceability.