CARDIO-PAK BASIC PUMP PACK— 510(k) K923231

Name: FDA 510(k) clearance K923231
Creator: U.S. Food and Drug Administration
Published: 1993-07-09

Unknown

Cardio-Med-Associates, Inc.

FDA 510(k) clearance K923231 for CARDIO-PAK BASIC PUMP PACK, Unknown on 1993-07-09. Applicant: Cardio-Med-Associates, Inc.. Device class: 2.

Clearance details

Applicant: Cardio-Med-Associates, Inc.
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 1992-07-01
Decision date: 1993-07-09
Decision: Unknown
Clearance type: Traditional
Location: Billings, MT, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

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.