Centri-Safe(Tm) Valve
FDA 510(k) K921500 · Cardio Systems, Inc.
510(k) numberK921500
Submission
- Device name
- Centri-Safe(Tm) Valve
- Applicant
- Cardio Systems, Inc.
Conshohocken, PA, US - Received
- March 31, 1992
- Decision date
- September 15, 1992
- 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 |
| 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 |
More from American Omni Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K131092 | Stealth 360 Orbital Pad SystemMCW · Special | 06/24/2013SE |
| K081944 | Modification to Diamondback 360 Degree Orbital Atherectomy SystemMCW · Special | 08/14/2008SE |
| K972022 | ZAK-2000FNM · Traditional | 01/22/1998SE |
| K934689 | Low Air Loss Mattress, ModificationINX · Traditional | 02/02/1994SE |
| K882177 | Add-On to Critical Patient Care BedIOQ · Traditional | 12/01/1988SE |
| K852736 | Baylor Rapid Autotransfusion SystemCAC · Traditional | 09/18/1985SE |
| K792152 | Cardioplegia Solution Admin. SetDWF · Traditional | 11/13/1979SE |
| K792151 | Oxygenator Gas Line FilterKRI · Traditional | 11/13/1979SE |
Questions and answers
When was Centri-Safe(Tm) Valve cleared by the FDA?
Centri-Safe(Tm) Valve (K921500) received a 510(k) decision of Substantially Equivalent on September 15, 1992, 168 days after the submission was received.
What is the product code of K921500?
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.