Models 430-07 & 431-07 Implantable Pacing Leads

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K890412 ↗

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. →

• Are these pacing leads designed for reuse in multiple patients, or are they intended for single-use only?

  These leads (Models 430-07 & 431-07) are explicitly intended for single-use implantation only. They are supplied sterile and meant to be used once per patient, adhering to clinical best practices for implantable cardiac devices.

• What types of storage conditions are recommended for these leads before use?

  While the exact storage instructions aren’t detailed in the provided data, the leads are sterile at time of supply, which implies they should be stored in their original packaging under clean, dry conditions—protected from contamination and extreme temperatures—until ready for use in a sterile clinical environment.

• How do I identify the correct model for my patient’s needs, and are there multiple sizes or configurations?

  The data doesn’t specify exact sizing or model variations beyond the two listed (430-07 & 431-07), but the product codes (DTB) and FDA clearance (K890412) suggest these are designed for standard permanent pacemaker electrode applications. Clinicians should consult manufacturer documentation or a cardiologist to confirm compatibility with the patient’s anatomy and pacing requirements.

• What regulatory pathway was followed for FDA clearance, and how does that affect my purchasing decision?

  These leads were cleared via a traditional 510(k) pathway (K890412) with a substantially equivalent (SESE) decision under FDA’s Class III (DTB) classification for permanent pacemaker electrodes. This means they meet FDA standards for safety and effectiveness as determined by the Cardiovascular (CV) Advisory Committee. Purchasers should verify compatibility with their institution’s procurement policies and ensure compliance with local healthcare regulations.