Catheter Balloon Dilator Pressure Gauge
FDA 510(k) K895511 · Argon Medical Corp.
510(k) numberK895511
Submission
- Device name
- Catheter Balloon Dilator Pressure Gauge
- Applicant
- Argon Medical Corp.
Athens, TX, US - Received
- September 12, 1989
- Decision date
- February 28, 1990
- 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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| K260035 | Digital Indeflator INFLANTEMAV · Traditional | UAB Telemedicina | 09/04/2026SE |
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| K162272 | Fluent inflation deviceMAV · Special | Vascular Solutions, Inc. | 10/20/2016SE |
| K153038 | Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special | Medtronic, Inc. | 04/13/2016SESK |
| 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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| K891022 | Introducer for Ptca Guiding CathetersDYB · Traditional | 05/19/1989SE |
| K884375 | Translumbar Aortography Needle CatheterDQR · Traditional | 01/11/1989SE |
| K882221 | Over the Needle Catheter, Arterial Catheter NeedleDYB · Traditional | 08/12/1988SE |
| K871297 | Kadir Hi-Torque Guide WireKOD · Traditional | 04/10/1987SE |
| K853312 | Argon Cut Biopsy Needles, Various SizesDWO · Traditional | 09/12/1985SE |
| K852880 | Peel-Away Sheath(A Component of Argon Introd Set)DYB · Traditional | 08/29/1985SE |
| K844555 | Pathfinder Cardiovascular CatheterDQO · Traditional | 03/27/1985SE |
Questions and answers
When was Catheter Balloon Dilator Pressure Gauge cleared by the FDA?
Catheter Balloon Dilator Pressure Gauge (K895511) received a 510(k) decision of Substantially Equivalent on February 28, 1990, 169 days after the submission was received.
What is the product code of K895511?
The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.