Endocardial Screw-In Lead 859 & 861

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

510(k) Number

K833824 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

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• Are these leads reusable or designed for single-use only, and how should they be handled post-implantation?

  The Endocardial Screw-In Leads 859 & 861 are explicitly designed for single-use implantation only. They are supplied sterile, meaning they are pre-sterilized by the manufacturer and intended to be used once before disposal. Since they are not meant for reuse, proper disposal protocols must follow local medical waste regulations to avoid contamination or reuse risks.

• What are the key differences between the Model 859 and Model 861 leads, and how might a clinician choose between them?

  The data provided does not specify technical differences between the Model 859 and Model 861 leads beyond their classification as two variants of the same product line. Clinicians would need to refer to the manufacturer’s detailed specifications or technical documentation for distinctions such as electrode design, coil configuration, or other functional attributes. Typically, such differences might relate to pacing thresholds, lead flexibility, or anatomical compatibility, but these are not outlined here.

• How should these leads be stored before use, and what are the shelf-life considerations?

  Since the leads are supplied sterile, they should be stored in their original, sealed packaging to maintain sterility until implantation. The manufacturer’s instructions (not provided here) would detail specific storage conditions, such as temperature ranges or protection from light. Shelf-life information is also typically included in the packaging or accompanying documentation, but the data here does not specify exact storage requirements or expiration timelines beyond their single-use, sterile state.

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

  The Endocardial Screw-In Leads 859 & 861 were cleared through the FDA’s 510(k) pathway, specifically under Traditional Review with a Substantially Equivalent (SESE) determination. The submission was reviewed by the Cardiovascular (CV) Advisory Committee, and the clearance was granted on December 1, 1983, following a filing received on October 31, 1983. These leads fall under Device Classification III (DTB) and are regulated under 21 CFR 870.3680.