Cobe Emergency Power Source 43610-000
FDA 510(k) K842138 · Cobe Laboratories, Inc.
510(k) numberK842138
Submission
- Device name
- Cobe Emergency Power Source 43610-000
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- May 30, 1984
- Decision date
- August 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4220
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DTQ
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|---|---|---|---|
| K232291 | Essenz HLM, Essenz ILBMDTQ · Special | Livanova Deutschland, GmbH | 08/24/2023SE |
| K221895 | Terumo Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 04/18/2023SE |
| K221373 | Essenz HLMDTQ · Traditional | Livanova Deutschland, GmbH | 03/09/2023SE |
| K210130 | Stockert S5 SystemDTQ · Special | Livanova Deutschland, GmbH | 04/05/2021SE |
| K202125 | Century Perfusion SystemDTQ · Traditional | Century Hlm, LLC | 03/07/2021SE |
| K190282 | Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)DTQ · Traditional | Spectrum Medical , Ltd. | 05/24/2019SE |
| K173834 | Quantum Pump ConsoleDTQ · Traditional | Spectrum Medical , Ltd. | 05/25/2018SE |
| K172220 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 08/17/2017SE |
| K163531 | Advanced Perfusion System 1DTQ · Traditional | Terumo Cardiovascular Systems Corporation | 06/07/2017SE |
| K153376 | Advanced Perfusion System 1DTQ · Special | Terumo Cardiovascular Systems Corporation | 12/16/2015SE |
More from Terumo Cardiovascular Systems Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K923272 | Cobe Cms-Hf Hollow Fiber Membrane OxygenatorDTZ · Traditional | 05/11/1993SE |
| K900105 | Cobe Spectra Blood Component Separator TherapeuticLKN · Traditional | 03/22/1991SE |
| K905793 | Cobe Centry 2 Bicart Option KitFKP · Traditional | 02/12/1991SE |
| K905388 | Cobe Centrysystem 3 Bicart Option KitFKP · Traditional | 02/11/1991SE |
| K904336 | New Cobe Saturation/Hematocrit MonitorGKF · Traditional | 12/27/1990SE |
| K902631 | Cobe ICU Conversion KitDTN · Traditional | 12/17/1990SE |
| K902437 | Cobe Cardiotomy Reservoir with or Without FilterDTP · Traditional | 12/17/1990SE |
| K904566 | New Cobe Centrysystem(Tm) 100 HG DialyzerFJI · Traditional | 12/12/1990SE |
| K902758 | Cobe Saturation/Hematocrit Monitor W/ Fiber OpticDQA · Traditional | 08/23/1990SE |
| K902759 | Cobe Closed Wound Drainage KitCAC · Traditional | 07/18/1990SE |
Questions and answers
When was Cobe Emergency Power Source 43610-000 cleared by the FDA?
Cobe Emergency Power Source 43610-000 (K842138) received a 510(k) decision of Substantially Equivalent on August 3, 1984, 65 days after the submission was received.
What is the product code of K842138?
The FDA product code is DTQ – Console, Heart-Lung Machine, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4220.