Myopore Unipolar Sutureless Myocardial Leads

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

Full name

Myopore(Tm) Unipolar Sutureless Myocardial Leads

510(k) Number

K885175 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Modification to Guarddog Occlusion System

  Class II

  FDA 510(k) K062220 Active Cleared 11 Aug 2006

• Fetch Aspiration Catheter

  Class II

  FDA 510(k) K070363 Active Cleared 11 May 2007

• Possis Angiojet X-Stream Rheolytic Thrombectomy Catheter, Model 103587-002

  Class II

  FDA 510(k) K993564 Active Cleared 28 Apr 2000

• Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040, 105042, 106552, 105043, 105041, 106553, 105039

  Class II

  FDA 510(k) K071342 Active Cleared 31 Jul 2007

• Angiojet Ultra Dvx Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior Thrombectomy Set, Model 105040-001

  Class II

  FDA 510(k) K090253 Active Cleared 8 Apr 2009

• Angiojet Xpeedior 120 Catheter and Angiojet Power Pulse Spray Ancillary Kit

  Class II

  FDA 510(k) K040013 Active Cleared 18 May 2004

See all devices from Possis Medical, Inc. →

• What types of patients are these leads designed to support with their cardiac function, and how do they differ from traditional pacemaker leads?

  The Myopore Unipolar Sutureless Myocardial Leads are specifically designed for patients with arrhythmias or conduction disorders requiring cardiac pacing. Unlike traditional pacemaker leads that require suturing to the myocardium, these leads attach directly to the heart muscle without stitches, simplifying implantation. Their unipolar design ensures focused electrical stimulation to maintain proper heart rhythm, making them suitable for patients who may benefit from a less invasive procedure.

• Are these leads compatible with multiple pacemaker systems, and how do I determine which model to use?

  Yes, the Myopore Unipolar Sutureless Myocardial Leads come in multiple model references to ensure compatibility with various pacemaker systems. To determine the correct model, consult your pacemaker manufacturer’s specifications or contact Possis Medical, Inc. for guidance, as the lead must match the pacing system’s requirements for optimal function.

• How should these leads be stored before use, and are they reusable?

  These leads are supplied sterile in packaging, meaning they are intended for single-use only and must remain unopened until implantation. Storage should follow the manufacturer’s instructions to maintain sterility, typically in a clean, dry environment away from direct sunlight or extreme temperatures. Reuse is not recommended or supported.

• Can these leads be used in patients who require MRI scans, and what safety considerations should be noted?

  Yes, these leads are approved for use in MRI environments, as indicated by their regulatory designation (870.3680). However, MRI safety depends on the specific scan parameters and equipment used. Always verify compatibility with your MRI facility’s protocols and consult the manufacturer’s guidelines to ensure patient safety during imaging.

• What should clinicians know about the regulatory pathway for these leads, and how does it impact their use?

  The Myopore Unipolar Sutureless Myocardial Leads were cleared through the FDA’s 510(k) process, classified as a Class III device under FDA regulations, with a decision of *Substantially Equivalent* (SESE) by the Cardiovascular (CV) Advisory Committee. This pathway ensures they meet stringent safety and effectiveness standards for permanent pacemaker electrodes. Clinicians should confirm the lead’s compatibility with their facility’s protocols and pacemaker systems, as the regulatory clearance confirms their design meets FDA requirements for cardiac pacing applications.