510(k) K142500
- Device
- One Way Soft Valve
- Applicant
- Terumo Cardiovascular Systems Corporation
- 510(k) number
- K142500
- Product code
- MJJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-01-29
- Date received
- 2014-09-05
- Regulation
- 870.4400
- Classification name
- Cpb Check Valve, Retrograde Flow, In-line
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Suzanne Grenier
- Address
- 28 Howe St. Ashland MA US 01721 01721
FDA Registration Numbers#
- 1928237
- 1718850
- 3017987980
- 1724474
- 1649914
Source Documents#
Other 510(k) Records For Product Code MJJ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K182442 | MiniGuard Arterial Safety Valve | Quest Medical, Inc. | 2018-11-06 |
| K001245 | 3T L. V. CONTROL VALVE | 3t Medical Systems, LLC | 2001-08-15 |
| K992785 | IBC FLOGUARD, MODEL 6050 | International Biophysics Corp. | 2000-01-14 |
| K982406 | COBE VACUUM RELIEF CHECK VALVE | Cobe Cardiovascular, Inc. | 1998-10-07 |
| K960937 | SUCTION SAFETY DEVICE | R D Intl. | 1996-06-05 |
| K922781 | FLOW CONROL VALVE | American Omni Medical, Inc. | 1993-03-08 |
| K922356 | FLOW CONTROL VALVE, CAT. NO. ACV-38 | American Omni Medical, Inc. | 1993-02-12 |
| K921500 | CENTRI-SAFE(TM) VALVE | Cardio Systems, Inc. | 1992-09-15 |
Legacy Summary#
summary
FDA Review#
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