ULTRA HIGH PRESSURE INJECTOR LINES— 510(k) K023591

Clearance details

Applicant

Deroyal Industries, Inc.

Product code

Code DQO

Device class

Class 2

Regulation

21 CFR 870.1200

Advisory panel

Cardiovascular

Date received

2002-10-25

Decision date

2003-06-18

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Powell, TN, US

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• K193027 — Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French2020-04-02

Death

35

Injury

993

Malfunction

1,772

Other

5

Total

2,805

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →