One Way Soft Valve
FDA 510(k) clearance K142500 · decided 2015-01-29
Clearance details
- K-number
- K142500
- Device name
- One Way Soft Valve
- Applicant
- Terumo Cardiovascular Systems Corporation
- Decision
- Substantially Equivalent
- Date received
- 2014-09-05
- Decision date
- 2015-01-29
- Days to decision
- 146 days
- Clearance type
- Traditional
- Product code
- MJJ
- Device class
- 2
- Regulation number
- 870.4400
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Ashland, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Terumo Cardiovascular Systems Corporation
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MiniGuard Arterial Safety Valve (K182442) | Quest Medical, Inc. | 2018-11-06 |
| 3T L. V. CONTROL VALVE (K001245) | 3t Medical Systems, LLC | 2001-08-15 |
| IBC FLOGUARD, MODEL 6050 (K992785) | International Biophysics Corp. | 2000-01-14 |
| COBE VACUUM RELIEF CHECK VALVE (K982406) | Cobe Cardiovascular, Inc. | 1998-10-07 |
| SUCTION SAFETY DEVICE (K960937) | R D Intl. | 1996-06-05 |
| FLOW CONROL VALVE (K922781) | American Omni Medical, Inc. | 1993-03-08 |
| FLOW CONTROL VALVE, CAT. NO. ACV-38 (K922356) | American Omni Medical, Inc. | 1993-02-12 |
| CENTRI-SAFE(TM) VALVE (K921500) | Cardio Systems, Inc. | 1992-09-15 |
Recalls involving this device
No recalls on record reference this clearance.