Heater Cooler Unit, Model Hcu 30
FDA 510(k) K031544 · Jostra AB
510(k) numberK031544
Submission
- Device name
- Heater Cooler Unit, Model Hcu 30
- Applicant
- Jostra AB
The Woodlands, TX, US - Received
- May 16, 2003
- Decision date
- August 7, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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).
Other 510(k)s with product code DWC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220635 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 11/16/2022SE |
| K212657 | Quantum Heater-CoolerDWC · Traditional | Spectrum Medical , Ltd. | 05/06/2022SE |
| K191402 | Heater-Cooler System 3TDWC · Traditional | Livanova Deutschland, GmbH | 02/25/2020SE |
| K140012 | Sorin FlexthermDWC · Special | Sorin Group Deutschland GmbH | 01/31/2014SE |
| K130300 | Heater-Cooler Unit Hcu 40DWC · Traditional | Maquet Cardiopulmonary, AG | 07/01/2013SE |
| K122813 | Hemotherm Model 400CE Cooler/Heater SystemDWC · Traditional | Cincinnati Sub-Zero Products, Inc. | 12/18/2012SE |
| K102147 | Cardioquip Modular Cooler-Heater Model MCH-1000DWC · Traditional | Cardioquip Llp | 11/19/2010SE |
| K071521 | Terumo HX2 Temperature Management SystemDWC · Traditional | Terumo Cardiovascular Systems Corp. | 11/21/2007SE |
| K052601 | Stockert Heater-Cooler System 3TDWC · Traditional | Sorin Group Deutschland GmbH | 06/06/2006SE |
| K014016 | Enguard CHC Dual Reservoir Cardioplegia Heater/CoolerDWC · Traditional | Minntech Corp. | 02/01/2002SE |
More from Minntech Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K020983 | Jostra Suckers, Model JSDWF · Traditional | 01/30/2004SE |
| K030264 | Quandrox Safeline Hollow Fiber Membrane Oxygenator, Model Hmo 2030DTZ · Special | 02/26/2003SE |
| K020784 | Jostra Single Stage Venous Return CathetersDWF · Traditional | 01/09/2003SE |
| K023132 | Jostra Mecc SystemKFM · Traditional | 12/17/2002SE |
| K022022 | Jostra Vent Catheters, Models LV & HKVDWF · Traditional | 09/11/2002SE |
| K020515 | Jostra Antegrade Cardioplegia CannulaDWF · Traditional | 04/24/2002SE |
| K014303 | Jostra Retrograde Cardioplegia CannulaeDWF · Traditional | 03/26/2002SE |
| K013944 | Jostra Dual Stage Venous Return CannulaeDWF · Traditional | 02/11/2002SE |
| K013939 | Jostra Flowprobe FP-32EDPT · Traditional | 12/14/2001SE |
| K012774 | Jostra Arterial Perfusion CannulaeDWF · Traditional | 11/16/2001SE |
Questions and answers
When was Heater Cooler Unit, Model Hcu 30 cleared by the FDA?
Heater Cooler Unit, Model Hcu 30 (K031544) received a 510(k) decision of Substantially Equivalent on August 7, 2003, 83 days after the submission was received.
What is the product code of K031544?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.