3M CDI H/S CUVETTES WITH HEPARON TREATMENT— 510(k) K973472

Substantially Equivalent

3M Healthcare

FDA 510(k) clearance K973472 for 3M CDI H/S CUVETTES WITH HEPARON TREATMENT, Substantially Equivalent on 1997-12-08. Applicant: 3M Healthcare.

Clearance details

Applicant: 3M Healthcare
Product code: Code DRY
Advisory panel: Cardiovascular
Date received: 1997-09-12
Decision date: 1997-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tistin, CA, US

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Adverse events under product code DRY

product code DRY

Death: 5
Total: 5

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.