Dorros-Spring Pressurizer
FDA 510(k) K812304 · Cardiovascular Diagnostic Services
510(k) numberK812304
Submission
- Device name
- Dorros-Spring Pressurizer
- Applicant
- Cardiovascular Diagnostic Services
Walker, MI, US - Received
- August 18, 1981
- Decision date
- October 13, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- MAV – Syringe, Balloon Inflation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1650
- Specialty
- Cardiovascular
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| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
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| K153672 | basixTOUCH40 Inflation SyringeMAV · Special | Merit Medical Systems, Inc. | 01/20/2016SESK |
| K152387 | Fluent Inflation DeviceMAV · Traditional | Vascular Solutions, Inc. | 12/18/2015SESK |
| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
| K143522 | Presto Inflation DeviceMAV · Traditional | C.R. Bard, Inc. | 01/12/2015SE |
| K133795 | Summed Inflation Device KitMAV · Traditional | Sunny Medical Device (Shenzhen) Co., Ltd. | 12/12/2014SE |
| K140745 | Encore 26 Advantage KitMAV · Special | Boston Scientific Corp | 04/17/2014SESK |
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| K903019 | Modified COAG-1 PT Test CardGJS · Traditional | 08/01/1990SE |
| K891015 | COAG-1 Aptt Test CardGFO · Traditional | 05/22/1989SE |
| K882456 | Coag-I PT Test CardGJS · Traditional | 08/25/1988SE |
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Questions and answers
When was Dorros-Spring Pressurizer cleared by the FDA?
Dorros-Spring Pressurizer (K812304) received a 510(k) decision of Substantially Equivalent on October 13, 1981, 56 days after the submission was received.
What is the product code of K812304?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.