HEMOBAG, MODEL HBBSD2000— 510(k) K031150

Name: FDA 510(k) clearance K031150
Creator: U.S. Food and Drug Administration
Published: 2003-06-23

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. Device class: 2.

Clearance details

Applicant: Global Blood Resources, LLC
Product code: Code DTN
Device class: Class 2
Regulation: 21 CFR 870.4400
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 ↗

Recent devices under product code DTN

view all

K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
K241206 — Quantum Perfusion Hybrid System2024-07-18
K241053 — MVR Venous Reservoir Bag 800 mL +3 more2024-05-15
K223361 — BMR 1900 PHISIO2023-06-10
K170583 — Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface2017-03-17

More clearances from Global Blood Resources, LLC

view all

K031151 — TS3 TUBING SET2003-06-26

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.