Coronary Sinus Guide and Lateral Vein Introducer Kits

• 2 recalls, same reason

  • Ongoing Z-2577-2024 FDA Class II ·initiated 11 Jun 2024
  • Ongoing Z-2571-2024 FDA Class II ·initiated 11 Jun 2024

  Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that may pose a risk to patient health.

510(k) Number

K120158 ↗

FDA Product Code

DYB

Device Class

Class II

Regulation

21 CFR Part 870.1340

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Multi-Port Y Introducer Set

  Class II

  FDA 510(k) K931587 Active Cleared 6 Oct 1993

• Reinforced Catheter Introducer System (Rcis)

  Class II

  FDA 510(k) K081341 Active Cleared 14 May 2008

• Long Length Percutaneous Introducer Set

  Class II

  FDA 510(k) K924456 Active Cleared 22 Mar 1993

• Hemodialysis Introducer Set

  Class II

  FDA 510(k) K961780 Active Cleared 24 Dec 1996

• Tear-Away Sheath Introducer Set with Integral Hemostasis Valve

  Class II

  FDA 510(k) K934901 Active Cleared 21 Jan 1994

• Transseptal Needle/Trocar

  Class II

  FDA 510(k) K011727 Active Cleared 2 May 2002

See all devices from Thomas Medical Products, Inc. →

• What is the primary use of the Coronary Sinus Guide and Lateral Vein Introducer Kits?

  These kits are designed specifically for assisting in the placement of leads or catheters into the coronary sinus and its lateral veins during cardiac resynchronization therapy (CRT) procedures. CRT is a treatment for heart failure that helps synchronize heart contractions by delivering electrical impulses to the heart’s lower chambers, improving overall heart function.

• Are the Coronary Sinus Guide and Lateral Vein Introducer Kits reusable or single-use?

  The kits are supplied as sterile, single-use devices. This ensures patient safety by preventing cross-contamination and maintaining device integrity for one-time procedural use only, as recommended by the manufacturer.

• How should these kits be stored to maintain sterility?

  Proper storage and handling per the manufacturer’s instructions are required to preserve sterility. This typically involves keeping the kits in their sealed packaging, away from direct sunlight or extreme temperatures, and ensuring the packaging remains unopened until immediate use in a sterile field.

• What regulatory approval does this device hold?

  The Coronary Sinus Guide and Lateral Vein Introducer Kits received FDA 510(k) clearance under the Cardiovascular advisory committee in 2012. This clearance indicates that the device is classified as substantially equivalent to a legally marketed predicate device and falls under Class II – Special Controls, ensuring compliance with specific regulatory standards.

• What types of procedures are these kits intended for?

  These kits are intended for use in cardiac electrophysiology labs, specifically for procedures involving the coronary sinus and its lateral veins. They are primarily utilized in cardiac resynchronization therapy (CRT) to facilitate precise vascular access, enabling accurate lead or catheter placement for treating heart failure.