Cardio Metrics Invasive Pressure Monit
FDA 510(k) K841960 · Sterile Design, Inc.
510(k) numberK841960
Submission
- Device name
- Cardio Metrics Invasive Pressure Monit
- Applicant
- Sterile Design, Inc.
Oldsmar, FL, US - Received
- May 14, 1984
- Decision date
- November 8, 1985
- 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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| 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 |
|---|---|---|
| K934688 | Sterile DesignLRO · Traditional | 03/16/1994SEKD |
| K842356 | Custom Sterile Procedure Kits · Traditional | 03/21/1985SE |
| K841959 | Cardio Metric Custom Perfusion TubingDWE · Traditional | 10/19/1984SE |
| K842351 | Sterile Design-Custom Sterile IV KitFPA · Traditional | 10/15/1984SE |
| K841958 | Cardio Metrics Cardiotomy ReservoirJOD · Traditional | 10/15/1984SE |
| K834239 | Sdi C-Flex Sterile Light Handle · Traditional | 04/25/1984SE |
| K834237 | Graduated Guide Wire Bowl 8DQX · Traditional | 02/04/1984SE |
| K813437 | Pan SetFRG · Traditional | 12/31/1981SE |
| K791738 | Custom Dressing Change TraysFMC · Traditional | 10/02/1979SE |
Questions and answers
When was Cardio Metrics Invasive Pressure Monit cleared by the FDA?
Cardio Metrics Invasive Pressure Monit (K841960) received a 510(k) decision of Substantially Equivalent on November 8, 1985, 543 days after the submission was received.
What is the product code of K841960?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.