The following data is part of a premarket notification filed by Stoeckert Instrumente with the FDA for Stockert A242 And A252 Series Arterial Femoral Cannulae.
| Device ID | K001961 |
| 510k Number | K001961 |
| Device Name: | STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | STOECKERT INSTRUMENTE 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Contact | Lynne Leonard |
| Correspondent | Lynne Leonard STOECKERT INSTRUMENTE 14401 W. 65th Way Arvada, CO 80004 -3599 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-27 |
| Decision Date | 2001-01-25 |