Origen Bladder Holder

FDA 510(k) K003145 · Origen Biomedical, Inc.

Substantially Equivalent

510(k) numberK003145

Submission

Device name
Origen Bladder Holder
Applicant
Origen Biomedical, Inc.
Austin, TX, US
Received
October 10, 2000
Decision date
April 20, 2001
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DWC – Controller, Temperature, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4250
Specialty
Cardiovascular
Life-sustaining
Yes

If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).

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K191402Heater-Cooler System 3TDWC · Traditional Livanova Deutschland, GmbH02/25/2020SE
K140012Sorin FlexthermDWC · Special Sorin Group Deutschland GmbH01/31/2014SE
K130300Heater-Cooler Unit Hcu 40DWC · Traditional Maquet Cardiopulmonary, AG07/01/2013SE
K122813Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional Cincinnati Sub-Zero Products, Inc.12/18/2012SE
K102147Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional Cardioquip Llp11/19/2010SE
K071521Terumo HX2 Temperature Management SystemDWC · Traditional Terumo Cardiovascular Systems Corp.11/21/2007SE
K052601Stockert Heater-Cooler System 3TDWC · Traditional Sorin Group Deutschland GmbH06/06/2006SE
K031544Heater Cooler Unit, Model Hcu 30DWC · Traditional Jostra AB08/07/2003SE

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K021702Cryobag, Model CBLPZ · Traditional 08/06/2002SE
K003288Origen Dual Lumen CatheterDQO · Traditional 06/08/2001SE

Questions and answers

When was Origen Bladder Holder cleared by the FDA?

Origen Bladder Holder (K003145) received a 510(k) decision of Substantially Equivalent on April 20, 2001, 192 days after the submission was received.

What is the product code of K003145?

The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.