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MapMate

by Ep Medsystems, Inc. 510(k)

Active United States

510(k) K063277

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK063277 Date30 Nov 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DQK
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The MapMate is an interface device that permits the automatic acquisition and logging of Carto point data onto the EP-Workmate Recording System. It is designed to reduce complexities related to documenting electrophysiology cases and allows clinicians to focus on patient care. The device enables the creation of complete EP case reports for easy documentation of procedure events.

The MapMate is supplied by EP Medsystems, Inc. and is authorized under FDA 510K clearance with product code DQK. It is a Class II device that integrates with electrophysiology laboratory equipment. The device is manufactured in West Berlin, New Jersey, and is designed for use in clinical settings for electrophysiology procedures.

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Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the MapMate device used for?

    The MapMate is used to automatically acquire and log Carto point data onto the EP-Workmate Recording System, reducing complexities in documenting electrophysiology cases and allowing clinicians to focus on patient care.

  • Is the MapMate device supplied sterile?

    The device data does not specify if the MapMate is supplied sterile, it is recommended to consult the manufacturer's instructions for use.

  • What type of clearance does the MapMate device have?

    The MapMate device is authorized under FDA 510K clearance with product code DQK, indicating it is substantially equivalent to a predicate device.