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Heparin Coated Thermodilution Catheter

by Kma, Inc.

510(k) K821099

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

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

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK821099 Date18 May 1982ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DYG
Device Class
Class II
Regulation
21 CFR Part 870.1240
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

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

This device is a Flow Directed Catheter (DYG classification) designed for thermodilution pulmonary artery pressure monitoring. It features a heparin coating to reduce thrombogenicity and improve compatibility with blood during cardiac catheterization procedures. The catheter enables accurate measurement of cardiac output and hemodynamic parameters by injecting a cold saline solution and analyzing the resulting temperature change in the pulmonary artery.

The Heparin-Coated Thermodilution Catheter is intended for single-use in clinical settings such as cardiac catheterization labs. It is supplied sterile and requires no additional sterilization. The device is classified as Class II under FDA regulation 870.1240 and was granted FDA 510(k) clearance (K821099) in 1982 under the Traditional 510(k) pathway. Multiple catheter sizes and configurations are available, as referenced in the associated FDA submissions, though exact dimensions are not specified in the regulatory data.

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