The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Jostra Hlm Tubing Sets With Safeline Coating.
| Device ID | K061832 |
| 510k Number | K061832 |
| Device Name: | JOSTRA HLM TUBING SETS WITH SAFELINE COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG 414 MARYJOE WAY Warrington, PA 18976 |
| Contact | James Collie |
| Correspondent | James Collie MAQUET CARDIOPULMONARY AG 414 MARYJOE WAY Warrington, PA 18976 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-29 |
| Decision Date | 2006-08-11 |
| Summary: | summary |