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Meritrans Disposable Transducer

by Merit Medical Systems, Inc.

510(k) K920977

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920977 Date11 Dec 1992ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

Full name
Meritrans(Tm) Disposable Transducer
510(k) Number
FDA product code
DRS
Device class
Class II
Regulation
21 CFR Part 870.2850
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 Meritrans Disposable Transducer is a blood-pressure transducer, extravascular, classified as a Class II medical device. It is designed for pressure monitoring in cardiovascular applications.

This device is supplied as a single-use transducer and has received FDA 510(k) clearance under K920977. It is intended for use in clinical settings where extravascular blood pressure monitoring is required.

From the manufacturer

Meritrans Pressure Transducers can be customised to fit your needs and offer reliable precision, unique configurations a a clear fluid path.

Source: merit.com

A range of single, double and triple disposable transducer sets Available with the Safedraw® safe arterial blood sampling system Designed with EasyVent® - a unique cap that allows clinicians to prime and zero the stopcock without removing the cap and exposing the line to the ambient environment.

Source: merit.com

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