Locator Model 4036

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

510(k) Number

K972814 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

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• AFP Cardiac Pacing System Model 283 (Modification)

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  FDA 510(k) K954714 Active Cleared 1 Feb 1996

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  FDA 510(k) K960854 Active Cleared 23 Dec 1996

• Passive Plus Pacing Leads with Titanium Nitride Coating

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  FDA 510(k) K951950 Active Cleared 31 Aug 1995

See all devices from Pacesetter, Inc. →

• What is the Locator Model 4036 used for in clinical practice?

  The Locator Model 4036 is a permanent pacemaker electrode designed to deliver electrical impulses to the heart for patients requiring chronic cardiac rhythm management. It ensures proper electrical conduction in the heart chambers, helping maintain normal heart function in patients with conditions like bradycardia or heart block.

• Is the Locator Model 4036 intended for single-use or reusable implantation?

  The Locator Model 4036 is sterile and intended for single-use only. It must be handled under sterile conditions before implantation to prevent infection or contamination, as reuse is not recommended or approved.

• How is the Locator Model 4036 regulated by the FDA, and what does that mean for purchasing?

  The Locator Model 4036 is a Class III medical device with FDA 510(k) clearance, classified as *substantially equivalent* with tracking requirements. This means it undergoes rigorous review for safety and effectiveness, and purchases may require compliance with FDA tracking regulations (e.g., reporting serial numbers). The device is also listed under product code DTB for cardiovascular pacemaker leads.

• What storage or handling precautions should be taken with the Locator Model 4036?

  Since the Locator Model 4036 is sterile and single-use, it must be stored in its original packaging until implantation to maintain sterility. The packaging should be kept dry, protected from contamination, and away from extreme temperatures. Always follow manufacturer guidelines for unpacking and handling to prevent compromise of sterility.