The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Quart Arterial Filter With Safeline Coating, Model Bsq-hbf 140.
| Device ID | K061546 |
| 510k Number | K061546 |
| Device Name: | QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 |
| Classification | Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Applicant | MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks MAQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTM |
| CFR Regulation Number | 870.4260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-05 |
| Decision Date | 2006-06-20 |
| Summary: | summary |