The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Edi Catheter Enfit.
| Device ID | K153688 |
| 510k Number | K153688 |
| Device Name: | Edi Catheter ENFit |
| Classification | Gastrointestinal Tubes With Enteral Specific Connectors |
| Applicant | MAQUET CRITICAL CARE AB RONTGENVAGEN 2 Solna, SE Se-171 54 |
| Contact | Mirva Boothe |
| Correspondent | Mark Dinger MAQUET MEDICAL SYSTEM USA 45 BARBOUR POND DRIVE Wayne, NJ 07470 |
| Product Code | PIF |
| CFR Regulation Number | 876.5980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-23 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17325710004675 | K153688 | 000 |
| 17325710004668 | K153688 | 000 |
| 17325710004651 | K153688 | 000 |
| 17325710004644 | K153688 | 000 |
| 17325710004637 | K153688 | 000 |
| 17325710004613 | K153688 | 000 |
| 17325710004606 | K153688 | 000 |