The following data is part of a premarket notification filed by Terumo Cardiovascular Systems Corp. with the FDA for Tenderflow Pediatric Venous Return Cannula.
| Device ID | K062597 |
| 510k Number | K062597 |
| Device Name: | TENDERFLOW PEDIATRIC VENOUS RETURN CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Contact | Christina L Thomas |
| Correspondent | Christina L Thomas TERUMO CARDIOVASCULAR SYSTEMS CORP. 6200 JACKSON RD. Ann Arbor, MI 48103 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-01 |
| Decision Date | 2006-11-03 |
| Summary: | summary |