INTERTIP INFUSION SET— 510(k) K934204

Name: FDA 510(k) clearance K934204
Creator: U.S. Food and Drug Administration
Published: 1994-02-07

Substantially Equivalent

Oasis Medical, Inc.

FDA 510(k) clearance K934204 for INTERTIP INFUSION SET, Substantially Equivalent on 1994-02-07. Applicant: Oasis Medical, Inc.. Device class: 2.

Clearance details

Applicant: Oasis Medical, Inc.
Product code: Code HQE
Device class: Class 2
Regulation: 21 CFR 886.4150
Advisory panel: Ophthalmic
Date received: 1993-08-30
Decision date: 1994-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glendora, CA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code HQE

product code HQE

Injury: 156
Malfunction: 565
Total: 721

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 →

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