Cobe Disposable Pressure Transducer
FDA 510(k) K810637 · Cobe Laboratories, Inc.
510(k) numberK810637
Submission
- Device name
- Cobe Disposable Pressure Transducer
- Applicant
- Cobe Laboratories, Inc.
Mchenry, IL, US - Received
- March 10, 1981
- Decision date
- April 23, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRS – Transducer, Blood-Pressure, Extravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2850
- Specialty
- Cardiovascular
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|---|---|---|---|
| K254074 | TruPressDRS · Traditional | Procerus Enterprises | 09/10/2026SE |
| K242909 | FloTrac sensors; FloTrac Jr sensors; Acumen IQ sensors; VolumeView sensorsDRS · Special | Edwards Lifesciences, LLC | 03/21/2025SE |
| K221782 | Meritrans ECO Reusable Pressure Transducer, Meritrans ECO DomesDRS · Traditional | Merit Medical Pte. , Ltd. | 03/17/2023SE |
| K172458 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 11/09/2017SE |
| K163172 | HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus…DRS · Traditional | Smiths Medical Asd, Inc. | 05/24/2017SE |
| K161408 | Compass Cast and MAPDRS · Traditional | Centurion Medical Products Corporation | 11/22/2016SE |
| K152472 | Disposable Pressure TransducerDRS · Traditional | Zhejiang Haisheng Medical Device Co., Ltd. | 10/31/2016SE |
| K152980 | Flo Trac sensor, Volume View sensorDRS · Traditional | Edwards Lifesciences, LLC | 01/19/2016SE |
| K151040 | Art-line Single channel blood pressure system, Art-line Double channel blood pressure…DRS · Traditional | Biometrix , Ltd. | 09/04/2015SE |
| K133624 | Compass CT, Compass CT PortDRS · Traditional | Mirador Biomedical | 04/18/2014SE |
More from Mirador Biomedical
| 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 Disposable Pressure Transducer cleared by the FDA?
Cobe Disposable Pressure Transducer (K810637) received a 510(k) decision of Substantially Equivalent on April 23, 1981, 44 days after the submission was received.
What is the product code of K810637?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.