Sutureless Muocardine Pacing Leads 471

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K781570 ↗

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 purpose of the Sutureless Myocardial Pacing Leads 471, and how does their design differ from traditional pacing leads?

  The Sutureless Myocardial Pacing Leads 471 are designed to deliver electrical pacing impulses directly to the myocardium (heart muscle) for patients with bradycardia or related conditions. Unlike traditional pacing leads that require sutures for secure attachment, these leads are engineered to attach directly to heart tissue without the need for stitching, simplifying the implantation process during minimally invasive procedures.

• Are these leads intended for single-use or can they be reused after implantation?

  These leads are explicitly supplied sterile and intended for single-use only. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and patient safety. Proper sterile handling and disposal protocols must be followed to maintain compliance with medical device regulations.

• What storage conditions should be followed for the Sutureless Myocardial Pacing Leads 471 to ensure sterility and functionality?

  Since these leads are sterile upon packaging, they must be stored in accordance with standard sterile medical device protocols. This includes keeping them in their original, unopened packaging, away from direct sunlight or extreme temperatures, and protecting them from physical damage. Always verify the expiration date and integrity of the packaging before use.

• What regulatory pathway was followed for FDA clearance of these leads, and which advisory committee was involved?

  The Sutureless Myocardial Pacing Leads 471 were cleared through the FDA 510(k) pathway under the classification of Class III medical devices (DTB). The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the decision was based on a determination of substantial equivalence (SESE) to a predicate device. The clearance number is K781570, filed in 1978.