Implantable Pacing Leads/Implantable Accessory/Non-Implantable Accessory

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

510(k) Number

K960281 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

ST

• Lifeline Unipolar Lead #487-05

  Class III

  FDA 510(k) K823508 Active Cleared 14 Jan 1983

• Implant Aid Splicing Crimp & Sleeve

  Class III

  FDA 510(k) K813518 Active Cleared 12 Jan 1982

• Veri-Vu Lensometer

  Class I

  FDA 510(k) K791521 Active Cleared 30 Oct 1979

• Implantable Pulse Generator Pacemakers

  Class III

  FDA 510(k) K791568 Active Cleared 19 Sep 1979

• Model 480-01 Pacing Lead

  Class III

  FDA 510(k) K844270 Active Cleared 28 Mar 1985

• GE Lead Adapter, Model 345-01

  Class II

  FDA 510(k) K801040 Active Cleared 30 Jun 1980

See all devices from Intermedics, Inc. →

• Are these pacing leads and accessories designed for reuse, or are they meant to be used only once after implantation?

  These leads and accessories are supplied sterile and intended for single-use implantation only. The device description explicitly states they are meant to be used once with an implantable pulse generator, ensuring patient safety and sterility standards.

• What types of models or model references should I expect when ordering these devices, and how do I identify the correct one for my procedure?

  This device includes multiple model references tracked under FDA clearance, such as 3002618605, 3008377825, 1028232, and others listed in the OpenFDA data. When ordering, verify the specific model number required for your patient’s case, as these leads may vary in design (e.g., implantable vs. non-implantable accessories) and intended positioning. Always cross-reference with your clinical protocol or manufacturer documentation.

• How are these leads regulated, and what does the FDA’s classification mean for their use in clinical practice?

  These leads are classified as Class 3 medical devices under FDA regulation 870.3680, meaning they undergo rigorous review for safety and effectiveness. The FDA granted 510(k) clearance (K960281) under the Traditional pathway, with a decision of *Substantially Equivalent* to a predicate device. This classification ensures they meet high standards for cardiovascular applications, particularly for regulating heart rhythm via electrical impulses, but does not imply any specific clinical indication beyond their intended use with implantable pulse generators.

• What storage conditions should I follow to maintain the sterility and functionality of these leads before use?

  While the data does not specify exact storage conditions, the leads are supplied sterile for single-use implantation. Standard practices for sterile medical devices—such as keeping them in a sealed, dry environment away from extreme temperatures or direct light—should be followed. Always adhere to the manufacturer’s instructions provided with the packaging to preserve sterility and integrity until use.

• Are these leads compatible with all implantable pulse generators, or are there specific systems they’re designed to work with?

  The device description states these leads are intended for use with implantable cardiac pulse generators, but it does not specify compatibility with particular brands or models. Compatibility depends on the manufacturer’s design specifications for each lead type (e.g., implantable vs. non-implantable accessories). Always verify compatibility with your chosen pulse generator’s documentation or consult the manufacturer to ensure proper integration and functionality.