Model 430-05 Polyflex Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K864287 ↗

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 430-05 Polyflex Implantable Pacing Lead designed for reuse or is it intended for single-use only?

  The Model 430-05 Polyflex Implantable Pacing Lead is explicitly designed for single-use implantation only. It is supplied sterile for direct surgical use, meaning it should not be reused after implantation to ensure patient safety and sterility.

• What types of storage conditions are required for the Model 430-05 Polyflex Implantable Pacing Lead before use?

  While the provided data does not specify exact storage conditions, the lead is sterile for direct surgical use, so it must be stored in its original packaging to maintain sterility. Standard medical device storage practices—such as protecting from extreme temperatures, moisture, and physical damage—should be followed until implantation.

• How is this device regulated by the FDA, and what does that mean for its use in clinical settings?

  The Model 430-05 Polyflex Implantable Pacing Lead is classified as a Class III device under FDA regulations and has received 510(k) clearance (K864287). This means it has undergone rigorous review by the FDA’s Cardiovascular (CV) advisory committee to ensure safety and effectiveness for its intended use in transvenous cardiac pacing. Clinicians should confirm compliance with the approved labeling and follow manufacturer guidelines for proper implantation and handling.

• What sizes or models of the Model 430-05 Polyflex Implantable Pacing Lead are available, and how do they differ?

  The provided data does not specify individual sizes or variations beyond the Model 430-05 designation, but the device is categorized under the DTB product code for transvenous pacing leads. For exact sizing options (e.g., coil length, electrode configuration, or catheter diameter), refer to the manufacturer’s technical documentation or catalog, as these details are not included in the regulatory submission.