UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM— 510(k) K894337

Name: FDA 510(k) clearance K894337
Creator: U.S. Food and Drug Administration
Published: 1989-09-29

Substantially Equivalent

Vitaid, Ltd.

FDA 510(k) clearance K894337 for UNIVENT TUBE 7.0MM, 7.5MM, 8.0MM, 8.5MM, 9.0MM, Substantially Equivalent on 1989-09-29. Applicant: Vitaid, Ltd.. Device class: 2.

Clearance details

Applicant: Vitaid, Ltd.
Product code: Code CBI
Device class: Class 2
Regulation: 21 CFR 868.5740
Advisory panel: Anesthesiology
Date received: 1989-07-14
Decision date: 1989-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ontario, Canada, CA

Download summary PDF View on FDA.gov ↗

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K932647 — WIRE REINFORCED ENDOTRACHEAL TUBE1993-11-02
K901738 — SELFCATH1990-06-27
K894883 — PHYCON ALL SILICONE BALLOON CATHETER1990-04-25
K894794 — AGISHI ASCITES PUMP PERITONEOCAVAL SHUNT PUMP1989-11-21

Adverse events under product code CBI

product code CBI

Death: 4
Malfunction: 594
Total: 598

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.