TRANSONIC FLOW-QC SET MODEL ADT1010— 510(k) K021571

Name: FDA 510(k) clearance K021571
Creator: U.S. Food and Drug Administration
Published: 2002-08-12

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K021571 for TRANSONIC FLOW-QC SET MODEL ADT1010, Substantially Equivalent on 2002-08-12. Applicant: Transonic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code MQS
Device class: Class 2
Regulation: 21 CFR 876.5820
Advisory panel: Gastroenterology, Urology
Date received: 2002-05-14
Decision date: 2002-08-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K021571

K-number listed on FDA's recall record

Z-1776-2018 — Transonic ADT1018 Flow QC Clear Advantage Tubing, Catalog No. ADT1018, ADT1018-40 The device is indicated for use as part of an extracorporeal blood circuit for hemodialysis when a monitor will be used to make access flow, recirculation, and/or cardiac output measurements during the patient s hemodialysis treatment.Class II·Terminated·Transonic Systems Inc·20180215

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K021571.

Data sourced from openFDA. This site is unofficial and independent of the FDA.