BAXA PCA INFUSOR— 510(k) K910257

Substantially Equivalent

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

FDA 510(k) clearance K910257 for BAXA PCA INFUSOR, Substantially Equivalent on 1991-11-07. Applicant: Baxa Corp., Sub. of Cook Group, Inc..

Clearance details

Applicant: Baxa Corp., Sub. of Cook Group, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 1991-01-22
Decision date: 1991-11-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Englewood, CO, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code MEA

product code MEA

Death: 19
Malfunction: 25,089
Total: 25,108

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.