Actifix Bipolar Endocardial Screw-in Lead

No FDA recalls on record, checked 22 Oct 2026.

Full name

Actifix (R) Bipolar Endocardial Screw-in Lead

510(k) Number

K874183 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Adapter Kit

  Class II

  FDA 510(k) K781864 Active Cleared 19 Dec 1978

• Pacemaker, Perm. & Temp., Electrode

  Class III

  FDA 510(k) K772197 Active Cleared 30 Jan 1978

• Permanent Lead Intraducer

  Class II

  FDA 510(k) K800356 Active Cleared 28 May 1980

• Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K800352 Active Cleared 28 May 1980

• Daig Pacel(Tm) Flow Directed Pacing Catheter

  Class II

  FDA 510(k) K890794 Active Cleared 20 Jun 1989

• Unipolar Lead Configuration Conductor

  Class III

  FDA 510(k) K800348 Active Cleared 28 May 1980

See all devices from Daig Corp. →

• What types of arrhythmias is this lead designed to manage, and how does it work?

  The Actifix Bipolar Endocardial Screw-in Lead is specifically designed for endocardial placement to deliver bipolar pacing stimulation to the heart. It is intended for patients with arrhythmias requiring cardiac rhythm management, such as bradycardia or certain atrial/ventricular conduction disorders. The lead’s bipolar design helps ensure precise stimulation, reducing the risk of oversensing or undersensing compared to unipolar leads.

• Is this lead reusable, or is it meant for single-use only?

  This lead is sterile upon supply and intended for single-use implantation only. It is not designed for reuse, which helps maintain patient safety and sterility standards during cardiovascular procedures.

• What sizes or models are available for this lead, and how is it packaged?

  The Actifix Bipolar Endocardial Screw-in Lead is available in multiple FEI (Final Equipment Identification) numbers, indicating different model variants (e.g., 3002618605, 1028232). Exact sizing details (e.g., lead length, coil diameter) are not specified in the provided data, but the device is supplied sterile and pre-packaged for surgical use. Contact Daig Corp. for specific model configurations.

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

  Since the lead is sterile and single-use, it should be stored in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The exact shelf-life isn’t detailed, but standard medical device storage guidelines (e.g., 2–8°C if refrigerated or room temperature if stable) typically apply. Always verify the expiration date printed on the packaging.

• What regulatory pathway was followed for FDA clearance, and how does this affect its use?

  The Actifix Lead received FDA 510(k) clearance (K874183) under the Traditional Review pathway, with a decision of Substantial Equivalence (SESE) to a predicate device. This means it was evaluated by the FDA’s Cardiovascular (CV) Advisory Committee and determined to have the same intended use and technological characteristics as a previously cleared device. Clinicians can rely on this clearance for permanent pacemaker electrode implantation in eligible patients, adhering to standard cardiovascular surgical protocols.