CARDIO-COOL— 510(k) K860523

Substantially Equivalent

Bio-Vascular, Inc.

FDA 510(k) clearance K860523 for CARDIO-COOL, Substantially Equivalent on 1986-04-29. Applicant: Bio-Vascular, Inc..

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 1986-02-12
Decision date: 1986-04-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

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.