LF CT HIG PRESSURE CATHETERS— 510(k) K945053

Substantially Equivalent

Mallinckrodt Group, Inc.

FDA 510(k) clearance K945053 for LF CT HIG PRESSURE CATHETERS, Substantially Equivalent on 1995-05-19. Applicant: Mallinckrodt Group, Inc..

Clearance details

Applicant: Mallinckrodt Group, Inc.
Product code: Code FOZ
Advisory panel: General Hospital
Date received: 1994-10-14
Decision date: 1995-05-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

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Adverse events under product code FOZ

product code FOZ

Death: 38
Injury: 2,290
Malfunction: 25,858
Other: 11
Total: 28,197

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.