BAXA TUBING SETS (FOR PHARMACY PUMP)— 510(k) K872743

Substantially Equivalent

Baxa Corp., Sub. of Cook Group, Inc.

FDA 510(k) clearance K872743 for BAXA TUBING SETS (FOR PHARMACY PUMP), Substantially Equivalent on 1987-10-09. Applicant: Baxa Corp., Sub. of Cook Group, Inc..

Clearance details

Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Product code: Code FMF
Advisory panel: General Hospital
Date received: 1987-07-13
Decision date: 1987-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

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Adverse events under product code FMF

product code FMF

Death: 15
Injury: 2,263
Malfunction: 29,722
Other: 17
Total: 32,017

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.