The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cath Sheath Introducer Syst Plus W/unistasis Valve.
| Device ID | K911794 |
| 510k Number | K911794 |
| Device Name: | CATH SHEATH INTRODUCER SYST PLUS W/UNISTASIS VALVE |
| Classification | Introducer, Catheter |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Mirjam Barboza |
| Correspondent | Mirjam Barboza CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-22 |
| Decision Date | 1991-07-19 |