Model 430-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862054 ↗

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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  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 primary purpose of the Model 430-01 Biopore Implantable Pacing Lead, and where is it typically implanted in the body?

  The Model 430-01 Biopore Implantable Pacing Lead is designed for transvenous implantation to stimulate the heart and regulate cardiac rhythm. It is specifically intended for use in the right ventricle or atrium, providing consistent pacing signals while integrating with surrounding tissue thanks to its Biopore coating.

• Is the Model 430-01 Biopore Implantable Pacing Lead intended for reuse, or is it meant for single-use only?

  The Model 430-01 Biopore Implantable Pacing Lead is explicitly supplied sterile and intended for single-use implantation during cardiac electrophysiology procedures. It is not designed for reuse.

• How is the Model 430-01 Biopore Implantable Pacing Lead packaged for surgical use, and what regulatory pathway was followed for its clearance?

  The lead is packaged sterile and ready for surgical use, as required for implantable medical devices. It received FDA 510(k) clearance through a traditional review pathway, with a decision of *Substantially Equivalent* by the Cardiovascular Advisory Committee, confirming its compliance with Class III device regulations (21 CFR 870.3680).

• What special considerations should be taken into account when storing or handling this device?

  The Model 430-01 Biopore Implantable Pacing Lead must be stored and handled according to the manufacturer’s instructions to maintain sterility and integrity. Since it is single-use and intended for surgical implantation, proper packaging should remain unopened until use, and disposal should follow medical device guidelines after implantation.