Pump Tubing
by Terumo Cardiovascular Systems Corporation
510(k) K013578
Pump Tubing is a Class II device made by Terumo Cardiovascular Systems Corporation, cleared under FDA 510(k) K013578 on 22 Jan 2002, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK013578 | Date22 Jan 2002 | StatusActive |
Official records
- FDA 510(k) database K013578
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DWE
- FDA applicant
- Terumo Cardiovascular Systems Corp.
- Device class
- Class II
- Regulation
- 21 CFR Part 870.4390
- Advisory committee
- Cardiovascular
- FDA decision
- SESE Substantially Equivalent
Similar devices
Other devices filed under FDA product code DWE (Tubing, Pump, Cardiopulmonary Bypass).
- Extracorp.'s Intersept CUS Tubing PK by Extracorporeal Medical Specialities, Inc.
- Traumafuse Perfusion Pressure Relief Valve by The Traumafuse Co.
- Smarxt Tubing and Connectors by LivaNova USA, Inc.
- CHEST DRAINAGE TUBING by Olson Medical Sales, Inc.
- CARDIOPULMONARY BYPASS PUMP TUBING by Texas Medical Products, Inc.
- HLM TUBING SET WITH BIOLINE COATING by Maquet Cardiopulmonary AG
- GENTLE HEADER by Enhanced Perfusion Systems, Inc.
- TYGON TUBING by Electromedics, Inc.
- VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT by Vortex Medical, Inc.
- AngioVac Circuit by ANGIODYNAMICS, INC
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