Polystan Heater-Cooler Unit
FDA 510(k) K893940 · Polystan C/O Vitalcor, Inc.
510(k) numberK893940
Submission
- Device name
- Polystan Heater-Cooler Unit
- Applicant
- Polystan C/O Vitalcor, Inc.
Denmark, DK - Received
- May 31, 1989
- Decision date
- January 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K031544 | Heater Cooler Unit, Model Hcu 30DWC · Traditional | Jostra AB | 08/07/2003SE |
More from Jostra AB
| 510(k) | Device | Decision |
|---|---|---|
| K894657 | Polystan Heart-Lung Machine SystemDJQ · Traditional | 03/28/1990SE |
| K893705 | SAFE-1 Venous ReservoirDTN · Traditional | 12/22/1989SE |
| K893704 | SAFE-1DTZ · Traditional | 12/22/1989SE |
| K874853 | Polystan Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K874852 | Polystan Wire Reinforced Two Stage CathetersDWF · Traditional | 02/05/1988SE |
| K872182 | Polystan Wire Reinforced Catheters and CannulaeDQY · Traditional | 10/30/1987SE |
| K843538 | Po 2 LytrodeDRY · Traditional | 10/18/1984SE |
Questions and answers
When was Polystan Heater-Cooler Unit cleared by the FDA?
Polystan Heater-Cooler Unit (K893940) received a 510(k) decision of Substantially Equivalent on January 18, 1990, 232 days after the submission was received.
What is the product code of K893940?
The FDA product code is DWC – Controller, Temperature, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4250.