The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Dual Stage Venous Return Cannulae.
| Device ID | K013944 |
| 510k Number | K013944 |
| Device Name: | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | JOSTRA AG 478 MEDIA RD. Oxford, PA 19363 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson JOSTRA AG 478 MEDIA RD. 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 | 2001-11-29 |
| Decision Date | 2002-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691362823 | K013944 | 000 |
| 04037691229492 | K013944 | 000 |
| 04037691056685 | K013944 | 000 |
| 04037691080260 | K013944 | 000 |
| 04037691479507 | K013944 | 000 |
| 04037691128948 | K013944 | 000 |
| 04037691079585 | K013944 | 000 |
| 04037691203416 | K013944 | 000 |
| 04037691223155 | K013944 | 000 |
| 04037691396965 | K013944 | 000 |
| 04037691020839 | K013944 | 000 |