The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Pump Tubing.
| Device ID | K013578 |
| 510k Number | K013578 |
| Device Name: | PUMP TUBING |
| Classification | Tubing, Pump, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Contact | Garry A Courtney |
| Correspondent | Garry A Courtney TERUMO CARDIOVASCULAR SYSTEMS CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | DWE |
| CFR Regulation Number | 870.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-29 |
| Decision Date | 2002-01-22 |
| Summary: | summary |