The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Arterial Perfusion Cannulae, Model A....
| Device ID | K012617 |
| 510k Number | K012617 |
| Device Name: | JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | JOSTRA AG P.O. BOX 218 Oxford, PA 19363 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson JOSTRA AG P.O. BOX 218 Oxford, PA 19363 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-13 |
| Decision Date | 2001-11-06 |
| Summary: | summary |