The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Pump Tubing.
| Device ID | K150542 |
| 510k Number | K150542 |
| Device Name: | Terumo Pump Tubing |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE STREET Ashland, MA 01721 |
| Contact | Joshua Ewing |
| Correspondent | Joshua Ewing TERUMO CARDIOVASCULAR SYSTEMS CORPORATION 28 HOWE STREET Ashland, MA 01721 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-05-01 |
| Summary: | summary |