ORIGEN BLADDER HOLDER— 510(k) K003145

Name: FDA 510(k) clearance K003145
Creator: U.S. Food and Drug Administration
Published: 2001-04-20

Substantially Equivalent

Origen Biomedical, Inc.

FDA 510(k) clearance K003145 for ORIGEN BLADDER HOLDER, Substantially Equivalent on 2001-04-20. Applicant: Origen Biomedical, Inc.. Device class: 2.

Clearance details

Applicant: Origen Biomedical, Inc.
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 2000-10-10
Decision date: 2001-04-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWC

view all

K220635 — Heater-Cooler System 3T2022-11-16
K212657 — Quantum Heater-Cooler2022-05-06
K191402 — Heater-Cooler System 3T2020-02-25
K140012 — SORIN FLEXTHERM2014-01-31
K130300 — HEATER-COOLER UNIT HCU 402013-07-01

More clearances from Origen Biomedical, Inc.

view all

K113869 — ORIGEN REINFORCED DUAL LUMEN CATHETER2012-07-26
K021702 — CRYOBAG, MODEL CB2002-08-06
K003288 — ORIGEN DUAL LUMEN CATHETER2001-06-08

Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.