TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM— 510(k) K961707

Name: FDA 510(k) clearance K961707
Creator: U.S. Food and Drug Administration
Published: 1997-03-11

Substantially Equivalent

Sorenson Critical Care

FDA 510(k) clearance K961707 for TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM, Substantially Equivalent on 1997-03-11. Applicant: Sorenson Critical Care. Device class: 1.

Clearance details

Applicant: Sorenson Critical Care
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 1996-05-02
Decision date: 1997-03-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Salt Lake City, UT, US

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Recent devices under product code BSY

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K031997 — MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM2003-11-25
K992902 — AMBU HAND POWER SUCTION PUMP1999-10-25
K982945 — DUAL PURPOSE CLOSED CATHETER1998-09-22
K981910 — SUCTION CATHETER1998-08-24
K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29

Adverse events under product code BSY

product code BSY

Death: 3
Injury: 155
Malfunction: 959
Total: 1,117

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.