Passive Plus Pacing Leads with Titanium Nitride Coating

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

510(k) Number

K951950 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESP Substantially Equivalent — Postmarket Surveillance

• Locator Model 4036

  Class III

  FDA 510(k) K972814 Active Cleared 23 Feb 1998

• Tendril Unipolar Endocardial Screw-In Lead

  Class III

  FDA 510(k) K951087 Active Cleared 29 Jun 1995

• DF-1 Terminal Cap

  Class III

  FDA 510(k) K954551 Active Cleared 26 Dec 1995

• Is-1/Quadripolar Terminal Cap, Part Number 6011069

  Class II

  FDA 510(k) K950140 Active Cleared 6 Apr 1995

• AFP Cardiac Pacing System Model 283 (Modification)

  Class III

  FDA 510(k) K954714 Active Cleared 1 Feb 1996

• Siemens Servo Ultra Nebulizer 345

  Class II

  FDA 510(k) K960854 Active Cleared 23 Dec 1996

See all devices from Pacesetter, Inc. →

• Are these pacing leads designed for reuse or single-use, and how should they be handled after opening?

  These Passive Plus Pacing Leads are supplied as sterile, single-use devices. They are intended for one-time use only and should not be reused or reprocessed. After opening, any unused portion must be discarded according to medical device disposal protocols to maintain sterility and patient safety.

• What specific models or part numbers are available for these titanium nitride-coated pacing leads?

  The Passive Plus Pacing Leads come in multiple model references, including 3002618605, 3008377825, 1028232, 3003574398, and others like 3008988055, 2183787, and 2182208. These variations ensure compatibility with various pacemaker systems, so verifying the correct model for your specific device is important.

• How does the titanium nitride coating benefit patients who require long-term cardiac pacing?

  The titanium nitride coating on these leads enhances biocompatibility, reducing the risk of adverse tissue reactions over time. This is particularly important for patients requiring long-term implantation, as it helps minimize complications like fibrosis or inflammation around the lead.

• What type of regulatory clearance does this device have, and how does that affect its use?

  These leads hold FDA 510(k) clearance under the classification of Permanent Pacemaker Electrode (DTB), regulated under 21 CFR 870.3680. This clearance indicates they meet U.S. regulatory standards for safety and effectiveness as intended for permanent transvenous cardiac pacing, ensuring they can be legally used in clinical settings following standard medical device protocols.

• Are these leads compatible with all pacemaker systems, or should I confirm compatibility before ordering?

  While the Passive Plus Pacing Leads are designed to work with various pacemaker systems, compatibility can vary depending on the specific model and manufacturer. It’s always best practice to verify the exact model number (e.g., 3002618605) against your pacemaker’s documentation to ensure proper function and safety before use.