Intermedics Poly Flex Epicardial Suture

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K812221 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

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See all devices from Intermedics, Inc. →

• What is the Intermedics Poly Flex Epicardial Suture used for in surgical settings?

  The Intermedics Poly Flex Epicardial Suture is specifically designed to secure epicardial leads to cardiac tissue during surgical procedures. Its flexible, biocompatible construction helps minimize tissue reaction while ensuring stable fixation, making it suitable for pacing or cardiac monitoring applications.

• Is the Intermedics Poly Flex Epicardial Suture intended for single-use or can it be reused?

  The device is explicitly labeled as a single-use suture. Reuse is not recommended or supported by the manufacturer, as it could compromise sterility and performance.

• What storage conditions are required to maintain the integrity of the Intermedics Poly Flex Epicardial Suture?

  The suture must be stored under conditions that preserve its sterility and structural integrity, as it is intended for use in sterile surgical environments. Specific storage instructions (e.g., temperature, packaging) are typically detailed in the manufacturer’s packaging or accompanying documentation.

• How is the regulatory status of this device determined, and what does it mean for its use?

  The device holds an FDA 510(k) clearance (K812221) under the classification of Class III (DTB), meaning it was deemed substantially equivalent to a legally marketed predicate device through a traditional review process. This clearance confirms its compliance with U.S. regulatory requirements for permanent pacemaker electrodes, ensuring safety and effectiveness for its intended surgical use.