HEMOBAG, MODEL HBBSD2000— 510(k) K031150

Substantially Equivalent

Global Blood Resources, LLC

FDA 510(k) clearance K031150 for HEMOBAG, MODEL HBBSD2000, Substantially Equivalent on 2003-06-23. Applicant: Global Blood Resources, LLC.

Clearance details

Applicant: Global Blood Resources, LLC
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 2003-04-10
Decision date: 2003-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windsor, CT, US

Download summary PDF View on FDA.gov ↗

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.