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

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..

Clearance details

Applicant: Mallinckrodt Dar S.R.L.
Product code: Code BSY
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 ↗

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.