Pace Implant. Lead/Tined/Atrial/J/Model 3290

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

510(k) Number

K864153 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Model 4205 Pulse Generator Surgical Exten Cable

  Class III

  FDA 510(k) K912545 Active Cleared 26 Jul 1991

• Model 4815 Adapter

  Class II

  FDA 510(k) K002496 Active Cleared 10 Oct 2000

• Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528

  Class II

  FDA 510(k) K001180 Active Cleared 27 Jun 2000

• Model 4800 Accupace Pacing System Analyer

  Class II

  FDA 510(k) K925143 Active Cleared 27 Sep 1994

• Model 3110 Heart Wire & 3110P Pediatric Heart Wire

  Class II

  FDA 510(k) K890988 Active Cleared 25 Aug 1989

• Pacing Leads Model 3262VU/Vb, 3362VU/Vb, 3380/3390

  Class III

  FDA 510(k) K874743 Active Cleared 19 Jan 1988

See all devices from Pace Medical →

• What is the primary purpose of the Pace Implant Lead Tined Atrial J Model 3290, and how does its design support this function?

  The Pace Implant Lead Tined Atrial J Model 3290 is designed specifically for atrial pacing, delivering electrical impulses to regulate heart rhythm in patients who require cardiac pacing support. Its tined, J-shaped configuration ensures secure fixation within the atrium, reducing the risk of dislodgment and improving long-term stability during implantation.

• Is this device intended for reuse, or is it meant to be used only once? How should it be handled to maintain integrity?

  This device is sterile and intended for single-use only. It must be handled with sterile techniques during implantation to preserve sterility and functionality, as reuse is not recommended by the manufacturer. Proper storage and packaging integrity are critical to maintaining its performance.

• What regulatory pathway was followed for this device’s approval, and which advisory committee reviewed it?

  The Pace Implant Lead Tined Atrial J Model 3290 received FDA 510(k) clearance (K864153) under the Traditional 510(k) review pathway, demonstrating substantial equivalence to a predicate device. The Cardiovascular (CV) Advisory Committee reviewed its submission, as indicated by the advisory committee designation.

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

  The provided data does not specify multiple sizes or models beyond the Model 3290, which is a tined, J-shaped atrial lead. However, the OpenFDA registration numbers suggest multiple lot or batch identifiers, which may relate to manufacturing variations rather than distinct clinical sizes. For precise sizing options, consult the manufacturer’s catalog or technical documentation.