INTERSEPT* VENOUS RESERVOIR BAG & HOLDER— 510(k) K803059

Substantially Equivalent

Extracorporeal Medical Specialities, Inc.

FDA 510(k) clearance K803059 for INTERSEPT* VENOUS RESERVOIR BAG & HOLDER, Substantially Equivalent on 1980-12-22. Applicant: Extracorporeal Medical Specialities, Inc..

Clearance details

Applicant: Extracorporeal Medical Specialities, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1980-12-03
Decision date: 1980-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.