The following data is part of a premarket notification filed by Cair L.g.l with the FDA for Carefusion Neutraclear Multi-fuse Extension Set With Needle-free Connector(s).
| Device ID | K171118 |
| 510k Number | K171118 |
| Device Name: | Carefusion NeutraClear Multi-fuse Extension Set With Needle-free Connector(s) |
| Classification | Set, Administration, Intravascular |
| Applicant | Cair L.G.L 1, Allee Des Chevreuils - Parc Tertiaire De Bois Dieu Lissieu, FR 69380 |
| Contact | Delphine Molinari |
| Correspondent | Delphine Molinari Cair L.G.L 1, Allee Des Chevreuils - Parc Tertiaire De Bois Dieu Lissieu, FR 69380 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-14 |
| Decision Date | 2017-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 13661657031409 | K171118 | 000 |
| 13661657031058 | K171118 | 000 |