COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163— 510(k) K063696

Substantially Equivalent

Baxterhealthcare, Inc.

FDA 510(k) clearance K063696 for COLLEAGUE VOLUMETRIC INFUSION PUMP MODEL# 2M8151,8153,8161,8163,9161,9163, Substantially Equivalent on 2007-02-27. Applicant: Baxterhealthcare, Inc..

Clearance details

Applicant: Baxterhealthcare, Inc.
Product code: Code FRN
Advisory panel: General Hospital
Date received: 2006-12-13
Decision date: 2007-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Deerfield Lake, IL, US

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Adverse events under product code FRN

product code FRN

Death: 540
Injury: 6,178
Malfunction: 1,464,165
Other: 52
Total: 1,470,935

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.