FLO-THRU— 510(k) K981624

Substantially Equivalent

Bio-Vascular, Inc.

FDA 510(k) clearance K981624 for FLO-THRU, Substantially Equivalent on 1998-08-04. Applicant: Bio-Vascular, Inc..

Clearance details

Applicant: Bio-Vascular, Inc.
Product code: Code DXC
Advisory panel: Cardiovascular
Date received: 1998-05-07
Decision date: 1998-08-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

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Adverse events under product code DXC

product code DXC

Death: 14
Injury: 442
Malfunction: 2,209
Other: 1
Total: 2,666

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.