The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Reflex Steerable Guidewire.
| Device ID | K905423 |
| 510k Number | K905423 |
| Device Name: | CORDIS REFLEX STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Katherine Trevisol |
| Correspondent | Katherine Trevisol CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-04 |
| Decision Date | 1991-03-01 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032054901 | K905423 | 000 |
| 20705032054864 | K905423 | 000 |
| 20705032054857 | K905423 | 000 |