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Disposable Catheter Pressure Transducer

by Deseret Medical, Inc. 2 variants

510(k) K894033

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 NumberK894033 Date17 Oct 1989ClearedStatusActive

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  • Withdrawn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
DXO
Device Class
Class II
Regulation
21 CFR Part 870.2870
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.

A disposable catheter pressure transducer is a device used to measure pressure at the tip of a catheter within the cardiovascular system. It is classified as a Class II medical device under regulation 870.2870 with product code DXO.

This device is supplied as a single-use, sterile transducer intended for use in cardiovascular procedures. It received FDA 510(k) clearance (K894033) on October 17, 1989, as substantially equivalent to a legally marketed predicate device.

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