CATHETER, IRRIGATION— 510(k) K770706

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K770706 for CATHETER, IRRIGATION, Substantially Equivalent on 1977-05-06. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code GBX
Advisory panel: General, Plastic Surgery
Date received: 1977-04-18
Decision date: 1977-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code GBX

product code GBX

Death: 16
Injury: 583
Malfunction: 3,578
Other: 1
Total: 4,178

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.