Pacesetter Sys Fast Pass Endocardial Lead 856 INLI

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K853914 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Vascutek Vascular Prothesis VP1200K/50K

  Class II

  FDA 510(k) K830016 Active Cleared 21 Dec 1983

• Vivalith 5 - MDL-201A & TDL-201A

  Class III

  FDA 510(k) K801763 Active Cleared 27 Aug 1980

• Cardiovascular Permanent Pacemaker Electrode

  Class III

  FDA 510(k) K891905 Active Cleared 5 Jun 1989

• Pacemaker Connector Plug

  Class II

  FDA 510(k) K821548 Active Cleared 2 Jun 1982

• Personal Medication Infuser

  Class II

  FDA 510(k) K830570 Active Cleared 24 Mar 1983

• Pacemaker Unipolar Adapter

  Class II

  FDA 510(k) K821547 Active Cleared 2 Jun 1982

See all devices from Pacesetter Systems →

• Is this lead designed for reuse in multiple patients, or is it intended for single-use only?

  This lead is explicitly supplied sterile and intended for single-use implantation only. The manufacturer’s description and regulatory classification (FDA 510(k)) confirm it is not meant for reuse across patients, aligning with standard practices for endocardial leads to ensure patient safety and sterility.

• What heart chambers is this lead approved for implantation within?

  The Pacesetter Sys Fast Pass Endocardial Lead 856 INLI is designed specifically for endocardial implantation, meaning it is intended for placement inside the heart’s chambers (e.g., right atrium or ventricle) to deliver pacing impulses. Its classification as a *permanent pacemaker electrode* reflects this purpose in cardiac electrophysiology procedures.

• How should this lead be stored before use, and what are the key handling considerations?

  Since the lead is sterile upon supply, it should be stored in its original packaging until immediately before use to maintain sterility. The single-use designation implies it must not be opened or handled beyond the manufacturer’s sterile barrier unless under aseptic conditions for implantation. Proper storage also involves protecting it from physical damage or contamination, as outlined for Class III medical devices.

• Are there multiple sizes or models available for this lead, or is it a single configuration?

  The provided data lists multiple FEI (Facility Establishment Identifier) numbers (e.g., 3002618605, 2183787), which typically correspond to different lot or batch identifiers rather than distinct sizes or models. However, no explicit size variations (e.g., coil length, tip configurations) are detailed in the description. For precise sizing options, consult the manufacturer’s catalog or technical specifications, as these may vary by clinical application.

• Does this lead have any specific compatibility requirements with MRI machines, or is it safe for patients who may need MRI scans?

  The lead adheres to MRI safety standards as required for its regulatory classification (Class III, product code DTB). However, the exact MRI compatibility (e.g., safe scan parameters or restrictions) is not detailed in the provided data. Clinicians should verify the manufacturer’s MRI safety information or labeling for the specific model before exposing patients to MRI environments, as risks depend on factors like coil design and scan protocols.