Skip to content

Flow-Directed Heparin Coated Thermodil

by Sorensen Research

510(k) K832957

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK832957 Date29 Sep 1983ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0305-04 FDA Unclassified (pre-2012) initiated 19 Nov 2003

    Thermodilution catheters have a potential for ruptured lumens within the catheter.

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  • Withdrawn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, 6 Oct 2026

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

This is a flow-directed, heparin-coated thermodilution catheter, classified as a cardiovascular device under FDA class 2. It is designed for use in hemodynamic monitoring to measure cardiac output and related parameters via thermodilution technique.

The device is supplied sterile and intended for single-use only. It received FDA 510(k) clearance (K832957) on September 29, 1983, under regulation number 870.1240, with product code DYG, and is manufactured by Sorensen Research in McHenry, Illinois.

Other devices from Sorensen Research

See all devices from Sorensen Research →