MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM— 510(k) K031997

Name: FDA 510(k) clearance K031997
Creator: U.S. Food and Drug Administration
Published: 2003-11-25

Substantially Equivalent

Mallinckrodt Dar S.R.L.

FDA 510(k) clearance K031997 for MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEM, Substantially Equivalent on 2003-11-25. Applicant: Mallinckrodt Dar S.R.L.. Device class: 1.

Clearance details

Applicant: Mallinckrodt Dar S.R.L.
Product code: Code BSY
Device class: Class 1
Regulation: 21 CFR 868.6810
Advisory panel: Anesthesiology
Date received: 2003-06-27
Decision date: 2003-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mirandola (Modena), IT

Download summary PDF View on FDA.gov ↗

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K972258 — HI-CARE CLOSED SUCTION SYSTEM1997-12-29
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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.