Spectramed Disposable Transducer (Dt-Xxo) & Access
FDA 510(k) K873168 · Spectramed, Inc.
510(k) numberK873168
Submission
- Device name
- Spectramed Disposable Transducer (Dt-Xxo) & Access
- Applicant
- Spectramed, Inc.
Oxnard, CA, US - Received
- August 11, 1987
- Decision date
- January 12, 1988
- 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 |
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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 |
|---|---|---|
| K896122 | Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. TippedKXO · Traditional | 01/19/1990SE |
| K892941 | Cco System Model SP1467,SP5567,SP6267KRB · Traditional | 11/06/1989SE |
| K895323 | Model Dt-Bal, Balance SaverKXO · Traditional | 10/24/1989SE |
| K894362 | Model DT-IUPC2 Transducer Tipped Dual Lumen IupKXO · Traditional | 08/15/1989SE |
| K881857 | Amnicath(Tm) Model Dt-Iupc Trans. Tipped Intrau.KXO · Traditional | 02/01/1989SE |
| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | 01/25/1989SE |
| K881825 | Models SP5825/SP5835/SP5845/SP5855 Percu. SheathDYB · Traditional | 09/28/1988SE |
| K875337 | Heparin Coated Luminal Pacing CatheterDQO · Traditional | 05/25/1988SE |
| K880740 | Model TA-CS10 Spectraject Control SyringeDQF · Traditional | 03/22/1988SE |
| K871573 | Central Venous Multi-Lumen Catheters and KitsDQY · Traditional | 09/16/1987SE |
Questions and answers
When was Spectramed Disposable Transducer (Dt-Xxo) & Access cleared by the FDA?
Spectramed Disposable Transducer (Dt-Xxo) & Access (K873168) received a 510(k) decision of Substantially Equivalent on January 12, 1988, 154 days after the submission was received.
What is the product code of K873168?
The FDA product code is DRS – Transducer, Blood-Pressure, Extravascular, a Class II (moderate risk) device regulated under 21 CFR 870.2850.