MiniGuard Arterial Safety Valve
FDA 510(k) K182442 · Quest Medical, Inc.
510(k) numberK182442
Submission
- Device name
- MiniGuard Arterial Safety Valve
- Applicant
- Quest Medical, Inc.
Allen, TX, US - Received
- September 7, 2018
- Decision date
- November 6, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MJJ – Cpb Check Valve, Retrograde Flow, In-Line
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4400
- Specialty
- Cardiovascular
Other 510(k)s with product code MJJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K142500 | One Way Soft ValveMJJ · Traditional | Terumo Cardiovascular Systems Corporation | 01/29/2015SE |
| K001245 | 3T L. V. Control ValveMJJ · Traditional | 3t Medical Systems, LLC | 08/15/2001SE |
| K992785 | Ibc Floguard, Model 6050MJJ · Traditional | International Biophysics Corp. | 01/14/2000SE |
| K982406 | Cobe Vacuum Relief Check ValveMJJ · Abbreviated | Cobe Cardiovascular, Inc. | 10/07/1998SE |
| K960937 | Suction Safety DeviceMJJ · Traditional | R D Intl. | 06/05/1996SE |
| K922781 | Flow Conrol ValveMJJ · Traditional | American Omni Medical, Inc. | 03/08/1993SE |
| K922356 | Flow Control Valve, Cat. No. ACV-38MJJ · Traditional | American Omni Medical, Inc. | 02/12/1993SE |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | Cardio Systems, Inc. | 09/15/1992SE |
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Questions and answers
When was MiniGuard Arterial Safety Valve cleared by the FDA?
MiniGuard Arterial Safety Valve (K182442) received a 510(k) decision of Substantially Equivalent on November 6, 2018, 60 days after the submission was received.
What is the product code of K182442?
The FDA product code is MJJ – Cpb Check Valve, Retrograde Flow, In-Line, a Class II (moderate risk) device regulated under 21 CFR 870.4400.