The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corporation with the FDA for Terumo Circuit Tubing.
| Device ID | K150536 |
| 510k Number | K150536 |
| Device Name: | Terumo Circuit Tubing |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721 |
| Contact | Garry Courtney |
| Correspondent | Garry Courtney Terumo Cardiovascular Systems Corporation 28 Howe Street Ashland, MA 01721 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-03 |
| Decision Date | 2015-05-05 |
| Summary: | summary |