Model 433-01 Biopore Implantable Pacing Lead

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K862259 ↗

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 433-01 Biopore Implantable Pacing Lead designed for reuse or single-use in clinical settings?

  The Model 433-01 Biopore Implantable Pacing Lead is explicitly intended for single-use implantation within the cardiovascular system. It is supplied sterile and meant for use in clinical settings by trained healthcare professionals, ensuring patient safety and sterility standards are maintained.

• What storage requirements must be followed to ensure the lead remains functional and sterile?

  The lead must be stored according to manufacturer guidelines to preserve sterility and functionality. Since it is supplied sterile and intended for single-use, proper storage conditions are critical to prevent contamination or degradation before implantation.

• How is this device classified under FDA regulations, and what pathway was used for its clearance?

  The Model 433-01 Biopore Implantable Pacing Lead is classified as a Class III device under regulation 870.3680 and was cleared via the traditional review pathway (510(k)) by the FDA. It was determined to be substantially equivalent to a predicate device, as noted in the clearance documentation.

• What type of patients is this lead intended to support, and how does its design address biocompatibility?

  This lead is designed for patients with bradycardia or conduction disorders requiring transvenous pacing. Its biocompatible design minimizes tissue reaction, reducing the risk of adverse responses during long-term implantation, which is critical for permanent pacemaker applications.