The following data is part of a premarket notification filed by Cobe Cardiovascular, Inc. with the FDA for Stockert V172 Series Venous Femoral Cannulae.
| Device ID | K001509 |
| 510k Number | K001509 |
| Device Name: | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard COBE CARDIOVASCULAR, INC. 14401 WEST 65TH WAY Arvada, CO 80004 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-05-15 |
| Decision Date | 2001-10-26 |