Continuous Flush Device
FDA 510(k) K813549 · Namic
510(k) numberK813549
Submission
- Device name
- Continuous Flush Device
- Applicant
- Namic
Walker, MI, US - Received
- December 21, 1981
- Decision date
- January 12, 1982
- 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 |
|---|---|---|
| K953676 | Breeze Digital Inflation DeviceMAV · Traditional | 03/29/1996SE |
| K951722 | Perceptor Compensator Morse ManifoldDRS · Traditional | 03/25/1996SE |
| K921322 | Morse Anesthesia ManifoldFPA · Traditional | 07/09/1993SE |
| K822100 | High Pressure Contrast Injection LineDQO · Traditional | 08/24/1982SE |
| K790083 | Catheter, Arterial LineDQY · Traditional | 01/25/1979SE |
| K790082 | Arterial Extension SetDQO · Traditional | 01/25/1979SE |
| K782095 | Stopcocks, ManifoldsDTL · Traditional | 01/23/1979SE |
Questions and answers
When was Continuous Flush Device cleared by the FDA?
Continuous Flush Device (K813549) received a 510(k) decision of Substantially Equivalent on January 12, 1982, 22 days after the submission was received.
What is the product code of K813549?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.