The following data is part of a premarket notification filed by Emmebi Srl with the FDA for Emmebi Central Venous Catheter Kit With Lestep Safety Introducer.
| Device ID | K043446 |
| 510k Number | K043446 |
| Device Name: | EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | EMMEBI SRL 6064 PARVIEW SE Grand Rapid, MI 49546 |
| Contact | Marjorie Bush |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-12-14 |
| Decision Date | 2005-02-04 |
| Summary: | summary |