The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Hls Cannula Non-coated, With Bioline Coating And With Softline Coating.
| Device ID | K102532 |
| 510k Number | K102532 |
| Device Name: | HLS CANNULA NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Ingrid Richter |
| Correspondent | Ingrid Richter MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-03 |
| Decision Date | 2011-02-25 |
| Summary: | summary |