Navigator Permanent Pacemaker Electrode

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

Full name

Navigator

510(k) Number

K853747 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Endomyocardial Biopsy Device

  Class II

  FDA 510(k) K870186 Active Cleared 20 Feb 1987

• Ciribart Gyudubg Catgeter

  Class II

  FDA 510(k) K855103 Active Cleared 18 Feb 1986

• Explorer Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K853850 Active Cleared 4 Dec 1985

• Wedge Pressure Catheter Flow Directed

  Class II

  FDA 510(k) K841705 Active Cleared 13 Jul 1984

• Percutaneous Transluminal Blood Dilation Catheter

  Class II

  FDA 510(k) K851848 Active Cleared 19 Jul 1985

• Transvenous Balloon Tipped(Flow Directed) Temp. Pa

  Class III

  FDA 510(k) K844752 Active Cleared 2 Jan 1985

See all devices from Mainsfield Scientific, Inc. →

• What types of heart conditions is the Navigator designed to address, and how does it work?

  The Navigator is a permanent pacemaker electrode intended for patients with bradycardia or conduction disorders, where the heart beats too slowly or irregularly. It delivers controlled electrical impulses to stimulate the heart muscle, ensuring a consistent and reliable heartbeat. This helps maintain proper cardiac function by compensating for impaired electrical signaling in the heart’s natural conduction system.

• Is the Navigator meant for reuse, or is it single-use only? How is it supplied?

  The Navigator is explicitly designed for single-use implantation only and is supplied sterile to ensure patient safety. It must be implanted by qualified medical professionals in a clinical setting, where sterile techniques are maintained. Reuse is not recommended or supported by the manufacturer.

• What model variations are available, and how do I determine compatibility with my pacemaker system?

  The Navigator comes in multiple model references, including 3002618605, 3008377825, and others (full list available in the specifications). Compatibility depends on your specific pacemaker system—always verify the model number against your device’s manufacturer guidelines or consult with your pacemaker supplier to ensure proper pairing before use.

• How should the Navigator be stored, and what precautions should be taken?

  Since the Navigator is sterile upon delivery, it should be stored in its original packaging until ready for use. Keep it in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the sterile barrier remains intact until implantation. Follow manufacturer instructions for expiration dates and handling to maintain sterility and performance.