HRT Series 100 Electrophysiology Catheter

by Heart Rhythm Technologies, Inc.

510(k) K932388

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K932388↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK932388	Date31 May 1995Cleared	StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K932388
FDA Product Code: DRF

Device Class: Class II
Regulation: 21 CFR Part 870.1220
Advisory Committee: Cardiovascular
FDA Decision: SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 HRT Series 100 Electrophysiology Catheter is an electrode recording catheter or probe. It is designed to detect intracardiac electrocardiograms or to detect cardiac output.

This device is authorized under FDA 510(k) number K932388. It is classified as a cardiovascular device.