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Reprocessed Sealed Electrophysiology Diagnostic Catheters

FDA 510(k)

Class II (US FDA 510(k))

510(k) K012678

by Sterilmed, Inc.

Identifiers

510(k) Number
K012678 FDA 510(k)
FDA Product Code
NLH FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1220 FDA 510(k)
Regulation Number
870.1220 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Reprocessed Sealed Electrophysiology Diagnostic Catheters are reprocessed, single-use, electrode catheters designed for intracardiac sensing, recording, and stimulation during electrophysiology studies. These devices facilitate temporary cardiac pacing and mapping of cardiac structures to evaluate arrhythmias, supporting diagnostic assessments in cardiovascular procedures.

These catheters are supplied in a sterile, sealed packaging and are intended for temporary use in electrophysiology laboratories. They are classified as Class II devices under FDA regulations (21 CFR 870.1220) and have received 510(k) clearance through the traditional review pathway by the FDA’s Cardiovascular Advisory Committee. Multiple model references (e.g., 3011276773, 3003076831) are included in the reprocessed batch, adhering to reprocessing standards for medical device reuse.

Frequently asked questions

What are these reprocessed catheters used for in electrophysiology studies?

These catheters are designed for intracardiac sensing, recording, and temporary cardiac stimulation during electrophysiology studies. They enable precise mapping of cardiac structures to diagnose arrhythmias, supporting diagnostic assessments in cardiovascular procedures. Their electrode design ensures accurate signal transmission for real-time arrhythmia evaluation.

Are these catheters supplied sterile and sealed, and how does that affect their use?

Yes, the catheters are supplied in sterile, sealed packaging to maintain sterility before use. This ensures a clean field during procedures, reducing infection risk. The sealed packaging also preserves the device’s integrity until immediate use, making them suitable for single-use applications in electrophysiology labs.

How many model references are included in the reprocessed batch, and why does this matter?

The reprocessed batch includes multiple model references (e.g., 3011276773, 3003076831), totaling over ten distinct FEI numbers. This variety allows clinicians to select the appropriate catheter based on patient anatomy, procedure requirements, or electrode configuration. It ensures compatibility with different electrophysiology study protocols while adhering to reprocessing standards for safe reuse.

Are these catheters intended for single-use or reuse, and what does reprocessing entail?

While originally designed as single-use, these catheters are reprocessed for reuse under strict medical device standards. Reprocessing involves cleaning, disinfection, inspection, and sterilization to restore the catheters to a safe, functional state. This allows healthcare facilities to extend their use while maintaining sterility and performance for subsequent electrophysiology procedures.

What regulatory pathway was followed for the FDA clearance of these catheters?

These catheters received FDA 510(k) clearance through the traditional review pathway, with the Cardiovascular Advisory Committee providing advisory input. The clearance was granted under the

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: REPROCESSED SEALED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS by STERILMED ..., Sterilmed Reprocessed Deflectable Electrophysiology Diagnostic Catheter ..., REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS by STERILMED, INC ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Sterilmed, Inc.

Sources (1)

  • FDA 510(k) K012678 24 fields · synced Oct 1, 2026