The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Railway Sheathless Access System.
| Device ID | K180081 |
| 510k Number | K180081 |
| Device Name: | RAILWAY Sheathless Access System |
| Classification | Introducer, Catheter |
| Applicant | Cordis Corporation 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Contact | Michelle Ragozzino Rodgers |
| Correspondent | Ankita Phophalia Cordis Corporation 1820 McCarthy Boulevard Milpitas, CA 95035 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-11 |
| Decision Date | 2018-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10705032076920 | K180081 | 000 |
| 10705032076845 | K180081 | 000 |
| 10705032076852 | K180081 | 000 |
| 10705032076869 | K180081 | 000 |
| 10705032076876 | K180081 | 000 |
| 10705032076883 | K180081 | 000 |
| 10705032076890 | K180081 | 000 |
| 10705032076906 | K180081 | 000 |
| 10705032076913 | K180081 | 000 |
| 10705032076838 | K180081 | 000 |