The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Three Stage Venous Return Cannula, Model 816460.
| Device ID | K080034 |
| 510k Number | K080034 |
| Device Name: | THREE STAGE VENOUS RETURN CANNULA, MODEL 816460 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Andrea Wallen |
| Correspondent | Andrea Wallen TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-07 |
| Decision Date | 2008-06-17 |
| Summary: | summary |