The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Steerable Coated Guidewire.
| Device ID | K894633 |
| 510k Number | K894633 |
| Device Name: | CORDIS STEERABLE COATED GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Contact | Rosemary Serbent |
| Correspondent | Rosemary Serbent CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-07-24 |
| Decision Date | 1989-10-17 |