The following data is part of a premarket notification filed by Mapquet Cardiopulmonary Ag with the FDA for Venous Bubble Trap, Model Vbt 160; Venous Bubble Trap With Bioline Coating, Model Be-vbt 160, Beq-vbt 160.
| Device ID | K082412 |
| 510k Number | K082412 |
| Device Name: | VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 |
| Classification | Defoamer, Cardiopulmonary Bypass |
| Applicant | MAPQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks MAPQUET CARDIOPULMONARY AG HECHINGER STRASSE 38 Hirrlingen, DE 72145 |
| Product Code | DTP |
| CFR Regulation Number | 870.4230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-08-21 |
| Decision Date | 2008-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04037691032528 | K082412 | 000 |
| 04037691075068 | K082412 | 000 |