PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM— 510(k) K092313

Substantially Equivalent

B.Braun Medical, Inc.

FDA 510(k) clearance K092313 for PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM, Substantially Equivalent on 2009-11-04. Applicant: B.Braun Medical, Inc..

Clearance details

Applicant: B.Braun Medical, Inc.
Product code: Code MEA
Advisory panel: General Hospital
Date received: 2009-07-30
Decision date: 2009-11-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Allentown, PA, US

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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.