The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Guide Wire For Edi Catheter 6 Fr, Guide Wire For Edi Catheter 8 Fr, 100 Cm, Guide Wire For Edi Catheter 8 Fr, 125 Cm.
| Device ID | K153461 |
| 510k Number | K153461 |
| Device Name: | Guide Wire For Edi Catheter 6 Fr, Guide Wire For Edi Catheter 8 Fr, 100 Cm, Guide Wire For Edi Catheter 8 Fr, 125 Cm |
| Classification | Tubes, Gastrointestinal (and Accessories) |
| Applicant | MAQUET CRITICAL CARE AB RONTGENVAGEN 2 Solna, SE Se-171 54 |
| Contact | Mirva Boothe |
| Correspondent | Linda Slutzky MAQUET MEDICAL SYSTEMS USA 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | KNT |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-01 |
| Decision Date | 2015-12-11 |
| Summary: | summary |