Intermedics 430-07 Bipol Implant Endocard Pac Lead

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

510(k) Number

K902672 ↗

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. →

• What is the primary clinical purpose of the Intermedics 430-07 Bipolar Implant Endocardial Pacemaker Lead, and how does its bipolar design benefit patients?

  The Intermedics 430-07 is designed for endocardial implantation to deliver bipolar pacing signals directly to the heart muscle, addressing bradycardia or other cardiac rhythm disorders requiring electrical stimulation. The bipolar design reduces the risk of muscle stimulation outside the pacing target area, improving pacing efficiency and minimizing discomfort for patients by focusing the electrical current more precisely.

• Is this device intended for reuse, or is it meant to be implanted as a single-use item? How does this affect handling and storage?

  This device is explicitly intended for single-use implantation and is supplied sterile. Because it is not designed for reuse, it must be handled under sterile conditions before implantation, and any unused portions should be discarded according to sterile medical device protocols. Storage should follow manufacturer guidelines to maintain sterility until use.

• What regulatory pathway was followed for FDA clearance, and which advisory committee reviewed this submission?

  The Intermedics 430-07 received FDA clearance through a Traditional 510(k) pathway (K902672) under the classification of a Class III medical device (870.3680). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its use in cardiovascular procedures. The decision was based on substantial equivalence to a predicate device.

• Are there multiple models or sizes available for this pacemaker lead, or is this a single standardized design?

  The provided data does not specify multiple models or sizes for the Intermedics 430-07 Bipolar Implant Endocardial Pacemaker Lead, implying it is likely offered as a standardized design for endocardial pacing. For exact sizing or variations, refer to the manufacturer’s technical documentation or catalog.