The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Antegrade Cardioplegia Cannula(n-type).
| Device ID | K140569 |
| 510k Number | K140569 |
| Device Name: | ANTEGRADE CARDIOPLEGIA CANNULA(N-TYPE) |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Sarah Betz |
| Correspondent | Sarah Betz MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-06 |
| Decision Date | 2014-11-19 |
| Summary: | summary |