The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Arterial Hls Cannula 13 Fr Non-coated, With Bioline Coating And With Softline Coating.
| Device ID | K131666 |
| 510k Number | K131666 |
| Device Name: | ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG NEUE ROTTENBURGER STR. 37 Hechingen, DE 72379 |
| Contact | Sarah Betz |
| Correspondent | Sarah Betz MAQUET CARDIOPULMONARY AG NEUE ROTTENBURGER STR. 37 Hechingen, DE 72379 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-07 |
| Decision Date | 2013-07-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691730677 | K131666 | 000 |
| 04037691730660 | K131666 | 000 |