The following data is part of a premarket notification filed by Jostra Ag with the FDA for Jostra Arterial Perfusion Cannulae.
| Device ID | K012774 |
| 510k Number | K012774 |
| Device Name: | JOSTRA ARTERIAL PERFUSION 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 | 2001-08-20 |
| Decision Date | 2001-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691396828 | K012774 | 000 |
| 04037691316437 | K012774 | 000 |
| 04037691140520 | K012774 | 000 |
| 04037691129983 | K012774 | 000 |
| 04037691063874 | K012774 | 000 |
| 04037691396736 | K012774 | 000 |
| 04037691396712 | K012774 | 000 |
| 04037691393285 | K012774 | 000 |
| 04037691396729 | K012774 | 000 |
| 04037691140599 | K012774 | 000 |
| 04037691086507 | K012774 | 000 |
| 04037691056692 | K012774 | 000 |
| 04037691396767 | K012774 | 000 |
| 04037691140407 | K012774 | 000 |