The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Guide Wire For Edi Catheter, 8fr,125cm,5 Each,guide Wire For Edi Catheter, 8fr,125cm,5 Each,guide Wire For Edi Catheter,.
| Device ID | K101199 |
| 510k Number | K101199 |
| Device Name: | GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, 8FR,125CM,5 EACH,GUIDE WIRE FOR EDI CATHETER, |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MAQUET CRITICAL CARE AB 45 BORBOUR POND DRIVE Wayne, NJ 07470 |
| Contact | Whitney Torning |
| Correspondent | Whitney Torning MAQUET CRITICAL CARE AB 45 BORBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-29 |
| Decision Date | 2010-08-27 |
| Summary: | summary |