Bio Pack Model 200
FDA 510(k) K853126 · Bio Medicus, Inc.
510(k) numberK853126
Submission
- Device name
- Bio Pack Model 200
- Applicant
- Bio Medicus, Inc.
Eden Prairie, MN, US - Received
- July 25, 1985
- Decision date
- October 11, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DWA – Control, Pump Speed, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4380
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K232788 | Inspira ART100DWA · Traditional | Inspira Technologies Oxy B.H.N. , Ltd. | 05/24/2024SE |
| K230698 | Anivia SG1000 Pump ConsoleDWA · Special | Apmtd, Inc. | 04/18/2023SE |
| K221491 | Anivia SG1000 Pump ConsoleDWA · Traditional | Apmtd, Inc. | 02/03/2023SE |
| K192838 | Quantumn Centrifugal Drive- High Pressure, Quantum Centrifugal Drive- Medium PressureDWA · Traditional | Spectrum Medical , Ltd. | 04/13/2020SE |
| K200306 | CentriMag Circulatory Support System, CentriMag Return (Arterial) Cannula Kit, CentriMag…DWA · Special | Abbott (Formerly Thoratec Corporation) | 03/06/2020SE |
| K191557 | CentriMag Acute Circulatory Support SystemDWA · Special | Thoratec Corporation (Now Part of Abbott) | 07/10/2019SE |
| K131964 | Bio-Console 560 Extracorporeal Blood Pumping ConsoleDWA · Special | Medtronic, Inc. | 07/24/2013SE |
| K131179 | Centrimag Primary Console (2ND Generation); Mag MonitorDWA · Special | Thoratec Corp | 07/18/2013SE |
| K112225 | Sorin Centrifugal Pump 5 (CP5)DWA · Special | Sorin Group Deutschland GmbH | 09/20/2011SE |
| K103468 | Stockert Centrifugal Pump (SCP Plus) (Complete) or (for S5/C5 Systems)DWA · Traditional | Sorin Group Deutschland GmbH | 01/20/2011SE |
More from Sorin Group Deutschland GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K920761 | Urine Cultur Stabilization Transport TubeLIO · Traditional | 06/19/1992SE |
| K903410 | Bio-Medicus Cannula IntroducerDYB · Traditional | 10/31/1990SE |
| K901253 | (PBS) Portable Bypass System, Model 1000DTZ · Traditional | 09/05/1990SE |
| K901584 | Bio-Medicus Bio Console Models 540 a B CDWA · Traditional | 06/28/1990SE |
| K894980 | Bio-Cal 370 Heater/CoolerDWJ · Traditional | 11/02/1989SE |
| K884129 | Bio-Medicus Percutaneous Cannula & Introducer SetDQY · Traditional | 12/21/1988SE |
| K883956 | Bio-Medicus Tubing ConnectorsDTL · Traditional | 10/28/1988SE |
| K872033 | Bio-Medicus Cannula-TubingDWF · Traditional | 12/07/1987SE |
| K861096 | Cardiopulmonary Cannula TubingDWF · Traditional | 05/21/1986SE |
| K854133 | Bio Medicus Bio Console 540DWA · Traditional | 01/08/1986SE |
Questions and answers
When was Bio Pack Model 200 cleared by the FDA?
Bio Pack Model 200 (K853126) received a 510(k) decision of Substantially Equivalent on October 11, 1985, 78 days after the submission was received.
What is the product code of K853126?
The FDA product code is DWA – Control, Pump Speed, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4380.