Medflator Ii(Tm) Disposable Inflation Device
FDA 510(k) K940896 · Medex, Inc.
510(k) numberK940896
Submission
- Device name
- Medflator Ii(Tm) Disposable Inflation Device
- Applicant
- Medex, Inc.
Hilliard, OH, US - Received
- February 24, 1994
- Decision date
- August 11, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special | Medtronic, Inc. | 04/13/2016SESK |
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| K140943 | Mastro Plus Balloon In-Deflation DeviceMAV · Traditional | Beijing Demax Medical Technology Co.,Ltd | 03/05/2015SE |
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| 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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| K982640 | Medex 3000 Series Syringe Infusion PumpFRN · Traditional | 04/06/1999ST |
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Questions and answers
When was Medflator Ii(Tm) Disposable Inflation Device cleared by the FDA?
Medflator Ii(Tm) Disposable Inflation Device (K940896) received a 510(k) decision of Substantially Equivalent on August 11, 1994, 168 days after the submission was received.
What is the product code of K940896?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.