Passive Plus Pacing Leads with Titanium Nitride Coating

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

510(k) Number

K952206 ↗

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 in multiple patients, or are they intended for single-use only?

  These leads are explicitly designed for single-use implantation during cardiac procedures. They are supplied sterile in packaging for immediate clinical use, requiring adherence to sterile surgical protocols. Reuse is not recommended or supported by the manufacturer.

• What special handling or storage instructions apply to these leads before and after opening the sterile packaging?

  The leads must be handled as sterile surgical instruments before use. They are supplied in sterile packaging for immediate clinical application, so once opened, they should be used promptly and discarded after a single procedure. Storage instructions are not explicitly detailed, but standard sterile supply protocols (e.g., refrigeration if required by facility policy) should apply to unopened packaging.

• How does the titanium nitride coating on these leads benefit patients compared to uncoated pacing leads?

  The titanium nitride coating enhances electrical conductivity, which improves pacing performance over time. It also reduces the risk of complications like thrombosis or fibrosis around the lead, potentially extending the longevity of the implant and minimizing the need for early revisions or replacements.

• Are these leads compatible with MRI procedures, and if so, under what conditions?

  Yes, these leads are compatible with MRI environments under specified conditions. While the exact parameters (e.g., MRI strength, sequence type, or safety distances) aren’t detailed in the data, the manufacturer acknowledges MRI compatibility, so clinicians should consult the device’s labeling or manufacturer guidelines for precise MRI safety protocols before use.

• What sizes or models of these pacing leads are available, and how do I determine the correct fit for a patient?

  The data does not specify exact sizes or model variants (e.g., atrial vs. ventricular leads, length, or electrode configurations). To determine the correct fit, clinicians should refer to the manufacturer’s catalog or consult with a Pacesetter representative, as lead selection depends on factors like patient anatomy, pacing requirements, and implantation site (e.g., right atrium, right ventricle).