CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS— 510(k) K902475

Substantially Equivalent

Cardio-Pak

FDA 510(k) clearance K902475 for CARDIO-PAK ANGIOGRAPHY CUSTOM PACKS, Substantially Equivalent on 1990-12-03. Applicant: Cardio-Pak.

Clearance details

Applicant: Cardio-Pak
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1990-06-04
Decision date: 1990-12-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Billings, MT, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.