The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Venous Hardshell Cardiotomy Reservoir; Non-coated, Non-tight/ Vacuum-tight/ With Softline Coating, Vacuum-tight.
| Device ID | K132166 |
| 510k Number | K132166 |
| Device Name: | VENOUS HARDSHELL CARDIOTOMY RESERVOIR; NON-COATED, NON-TIGHT/ VACUUM-TIGHT/ WITH SOFTLINE COATING, VACUUM-TIGHT |
| Classification | Reservoir, Blood, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Ingrid Richter |
| Correspondent | Ingrid Richter MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Product Code | DTN |
| Subsequent Product Code | DTP |
| Subsequent Product Code | JOD |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-12 |
| Decision Date | 2013-10-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04058863019222 | K132166 | 000 |
| 04037691838663 | K132166 | 000 |
| 04037691854984 | K132166 | 000 |
| 04037691906942 | K132166 | 000 |
| 04037691913032 | K132166 | 000 |
| 04037691965307 | K132166 | 000 |
| 04037691965628 | K132166 | 000 |
| 04037692009987 | K132166 | 000 |
| 04037692009994 | K132166 | 000 |
| 04037692011362 | K132166 | 000 |
| 04037692010013 | K132166 | 000 |
| 04058863005805 | K132166 | 000 |
| 04058863007403 | K132166 | 000 |
| 04058863017792 | K132166 | 000 |
| 04058863018843 | K132166 | 000 |
| 04058863018867 | K132166 | 000 |
| 04037691833545 | K132166 | 000 |