The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Steerable Guidewires.
| Device ID | K950316 |
| 510k Number | K950316 |
| Device Name: | CORDIS STEERABLE GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald 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 | 1995-01-26 |
| Decision Date | 1995-04-14 |