Kardium, Inc.

Kardium, Inc. specializes in reusable electrical connection cables for medical devices, such as cardiac mapping systems (e.g., workstations, reference patches, and electrode-based positioning systems). They also produce cardiac irreversible electroporation systems, including generator units, catheter platforms (often single-use), and accessories like cable holders and introducer tools. These devices are designed for procedures involving cardiac interventions and electrophysiological mapping.

Kardium, Inc. is headquartered in the United States. While the company’s devices are primarily intended for use in the U.S., regulatory submissions (such as 510(k), PMA, and UDI listings) reflect compliance with FDA requirements for devices marketed there. The company’s focus aligns with U.S. medical device regulations and standards.

Kardium, Inc.’s devices are documented in U.S. regulatory submissions, including FDA’s 510(k) premarket notifications, Premarket Approval Applications (PMA), and Unique Device Identifier (UDI) listings. These registries reflect the company’s compliance pathways for devices classified under FDA categories Class I, II, and III, ensuring traceability and regulatory oversight.

Kardium, Inc.’s devices span multiple FDA risk classifications: Class I (low-risk, general controls), Class II (moderate-risk, requiring special controls), and Class III (high-risk, requiring premarket approval). The classification depends on factors like device purpose, patient contact type, and procedural invasiveness—for example, irreversible electroporation systems fall under Class III due to their advanced therapeutic role, while reusable cables may qualify for Class I or II based on their intended use and risk profile.