FlexSeal Introducer Sheath with Hydrophilic Coating— 510(k) K190628

Substantially Equivalent

Freudenberg Medical Mis, Inc.

FDA 510(k) clearance K190628 for FlexSeal Introducer Sheath with Hydrophilic Coating, Substantially Equivalent on 2019-05-30. Applicant: Freudenberg Medical Mis, Inc..

Clearance details

Applicant: Freudenberg Medical Mis, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2019-03-12
Decision date: 2019-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Jeffersonville, IN, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.