510(k) K150542
- Device
- Terumo Pump Tubing
- Applicant
- TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
- 510(k) number
- K150542
- Product code
- DWE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-05-01
- Date received
- 2015-03-03
- Regulation
- 870.4390
- Classification name
- Tubing, Pump, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOSHUA EWING
- Address
- 28 Howe St. Ashland MA US 01721 01721
FDA Registration Numbers#
- 9617601
- 2029275
- 1043214
- 2520313
- 3019807891
- 1721676
- 3015537049
- 2184009
- 1319211
- 1724474
- 3009380063
- 3005941719
- 3017987980
- 2011171
- 1124841
- 1319639
- 1000523114
- 1928237
- 1222928
- 1718850
Source Documents#
Other 510(k) Records For Product Code DWE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K233702 | SMARxT Tubing and Connectors | LivaNova USA, Inc. | 2024-08-08 |
| K142607 | AngioVac Circuit | Angiodynamics | 2014-12-11 |
| K092486 | VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT | Vortex Medical, Inc. | 2009-08-28 |
| K080592 | HLM TUBING SET WITH BIOLINE COATING | Maquet Cardiopulmonary, AG | 2008-09-11 |
| K053025 | JOSTRA HLM TUBING SET | Maquet Cardiopulmonary, AG | 2005-11-10 |
| K022857 | PUMP TUBING WITH X-COATING | Terumo Cardiovascular Systems Corporation | 2002-09-19 |
| K013578 | PUMP TUBING | Terumo Cardiovascular Systems Corp. | 2002-01-22 |
| K993189 | CARDIOPULMONARY BYPASS PUMP TUBING - 1/4 INCH TUBING, CARDIOPULMONARY BYPASS PUMP TUBING - 3/8 INCH TUBING | Terumo Corp. | 2000-03-01 |
| K993062 | CHEST DRAINAGE TUBING | Olson Medical Sales, Inc. | 1999-12-10 |
| K981613 | COBE SMARXT TUBING AND CONNECTORS | Cobe Cardiovascular, Inc. | 1998-10-26 |
| K923231 | CARDIO-PAK BASIC PUMP PACK | Cardio-Med-Associates, Inc. | 1993-07-09 |
| K905686 | SARNS TEMPERATURE PROBE AND CONNECTOR | 3M Health Care, Sarns | 1991-02-25 |
| K902845 | GENTLE HEADER | Enhanced Perfusion Systems, Inc. | 1990-12-03 |
| K894721 | TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE | The Traumafuse Co. | 1989-10-20 |
| K841959 | CARDIO METRIC CUSTOM PERFUSION TUBING | Sterile Design, Inc. | 1984-10-19 |
Legacy Summary#
summary
FDA Review#
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