The following data is part of a premarket notification filed by Maquet Cardiopulmonary Ag with the FDA for Elite-i (bi) Dual Lumen Catheter; Elite-i (ra) Dual Lumen Catheter; Elite-i (bix)dual Lumen Catheter.
| Device ID | K130639 |
| 510k Number | K130639 |
| Device Name: | ELITE-I (BI) DUAL LUMEN CATHETER; ELITE-I (RA) DUAL LUMEN CATHETER; ELITE-I (BIX)DUAL LUMEN CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Contact | Katrin Schwenkglenks |
| Correspondent | Katrin Schwenkglenks MAQUET CARDIOPULMONARY AG KEHLER STRASSE 31 Rastatt, DE 76437 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-11 |
| Decision Date | 2013-05-16 |
| Summary: | summary |