The following data is part of a premarket notification filed by Jostra Ag with the FDA for Els Cannula (kit), Model M1210-88,m1510-88.
| Device ID | K002857 |
| 510k Number | K002857 |
| Device Name: | ELS CANNULA (KIT), MODEL M1210-88,M1510-88 |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | JOSTRA AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson JOSTRA AG 2035 SUNSET LAKE RD. Newark, DE 19702 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-13 |
| Decision Date | 2000-10-05 |