Suction Safety Device
FDA 510(k) K960937 · R D Intl.
510(k) numberK960937
Submission
- Device name
- Suction Safety Device
- Applicant
- R D Intl.
Richardson, TX, US - Received
- March 8, 1996
- Decision date
- June 5, 1996
- 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 |
|---|---|---|---|
| K182442 | MiniGuard Arterial Safety ValveMJJ · Traditional | Quest Medical, Inc. | 11/06/2018SE |
| 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 |
| 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 |
More from Cardio Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960312 | Rdi Cardiac Insulation PadDWP · Traditional | 04/19/1996SE |
Questions and answers
When was Suction Safety Device cleared by the FDA?
Suction Safety Device (K960937) received a 510(k) decision of Substantially Equivalent on June 5, 1996, 89 days after the submission was received.
What is the product code of K960937?
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.