Cpb Check Valve, Retrograde Flow, In-Line
FDA product code MJJ · Class II (moderate risk) · 21 CFR 870.4400 · Cardiovascular
9510(k) clearances
0PMA approvals
36recalls
Manufacturers
510(k) clearances
| 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 |
| K921500 | Centri-Safe(Tm) ValveMJJ · Traditional | Cardio Systems, Inc. | 09/15/1992SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3252-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 2, REV:6 X-Coated FX Perfusion Pack…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3251-2011 | Cardiovascular Custom Procedure Kits, REV: 3, REV: 3A, REV:4 FX, CP50 CENT. PK Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3250-2011 | Cardiovascular Custom Procedure Kits, REV: 4 FX, CP50 CENT. PK Item Number: 73386 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3249-2011 | Cardiovascular Custom Procedure Kits, REV: 8 Comprensive X-COATED 8000 FX PK Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3248-2011 | Cardiovascular Custom Procedure Kits, REV: 1A, REV :1 X-COATED FX PK Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3247-2011 | Cardiovascular Custom Procedure Kits, REV: 2A, REV: 2B X-COATED FX PK Item Number: 73191…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3246-2011 | Cardiovascular Custom Procedure Kits, REV: 1 REV: 1A COATED FX PK Item Number: 72985-02…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3245-2011 | Cardiovascular Custom Procedure Kits, REV: 0, REV: 1 REV: 4, REV: 6A, REV: 6B. REV: 6C…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3244-2011 | Cardiovascular Custom Procedure Kits, REV: 2, REV:2A, REV: 5, REV: 7 X-Coated FX…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3243-2011 | Cardiovascular Custom Procedure Kits, REV : 3 General Low Prime Item Number: 73563…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3242-2011 | Cardiovascular Custom Procedure Kits, REV : 2, REV: 4 FX, CP50,CENT Pack Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3241-2011 | Cardiovascular Custom Procedure Kits, REV :3. REV: 4, REV: 5, REV: 6, REV:7 X-Coated…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3240-2011 | Cardiovascular Custom Procedure Kits, REV :2. REV 2A, REV: 17, REV 18 X-COATED FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3239-2011 | Cardiovascular Custom Procedure Kits, REV :10. REV 13, REV17, REV 18 FX X-Coated…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3238-2011 | Cardiovascular Custom Procedure Kits, REV: 5 STANDARD PACK Item Number: 71701 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3237-2011 | Cardiovascular Custom Procedure Kits, REV: 5 X-COATED FPS ADULT PACK Item Number: 73325…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3236-2011 | Cardiovascular Custom Procedure Kits, REV: 1 X-COATED 3/8 X 1/2 A-V LOOP Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3235-2011 | Cardiovascular Custom Procedure Kits, REV: 2 X-COATED 3/8 X 3/8 A-V LOOP Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3234-2011 | Adjustable Valve Item Number: 73631 Terumo Cardiovascular Systems, Ashland, MA 01721 The…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3233-2011 | Cardiovascular Custom Procedure Kits, REV.0 FX 8:1 PACK Item Number: 73329 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3232-2011 | Cardiovascular Custom Procedure Kits, REV.0, REV 1, REV 1A, REV. 2 XCoated 8:1 FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3231-2011 | Cardiovascular Custom Procedure Kits, REV.4, REV. 5 X-COATED NEONATAL PACK 3/16" Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3230-2011 | Cardiovascular Custom Procedure Kits, REV.OB PERFUSION W/8:1 CARDIOPLEGIA Item Number:…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3229-2011 | Cardiovascular Custom Procedure Kits, REV.3, REV. 5 X-COATED 8:1 CARDIOPLEGIA Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3228-2011 | Cardiovascular Custom Procedure Kits, REV.2, REV. 3 PUMP & TABLE PACK 1/4 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3227-2011 | Cardiovascular Custom Procedure Kits, REV..1 X-Coated Stand Alone Adult Pack Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3226-2011 | Cardiovascular Custom Procedure Kits, REV.0 REV.0A, REV.1 X-Coated 4:1 CP50 FX Pack Item…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3225-2011 | Cardiovascular Custom Procedure Kits, Rev O X-Coated 8:1 CP No OXY Item Number: 73329…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3224-2011 | Cardiovascular Custom Procedure Kits, Rev OA FX 8:1 PACK Item Number :73315 Terumo…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3223-2011 | Cardiovascular Custom Procedure Kits, Rev O, REV 1, REV 1A, REV 2 X-COATED 8:1 FX PACK…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3222-2011 | Cardiovascular Custom Procedure Kits, REV OA PERFUSION W/4:1 CARDIOPLEGIA Item Number…3-T Medical Systems one way vent valves, included in the Custom Terumo Cardiovascular kits, may separate at… | Terumo Cardiovascular Systems Corp | 08/11/2011Terminated |
| Z-3062-2011 | TruChoice Alliant Healthcare Products, REFERENCE# SSD-100EX, QUANTITY: 25, DESCRIPTION:…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | Alliant Enterprises LLC | 07/21/2011Terminated |
| Z-3061-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | Alliant Enterprises LLC | 07/21/2011Terminated |
| Z-3060-2011 | Non-Adjustable Vent Valve, TruChoice Alliant Healthcare Products, REFERENCE#213-035NS…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | Alliant Enterprises LLC | 07/21/2011Terminated |
| Z-3059-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030NS…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | Alliant Enterprises LLC | 07/21/2011Terminated |
| Z-3058-2011 | Adjustable Vent Valve, TruChoice Alliant Healthcare Products REFERENCE#213-030 QUANTITY:…The firm is initiating this recall due to the receipt of 2 complaints of malfunction of the joint holding… | Alliant Enterprises LLC | 07/21/2011Terminated |