The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Vanguard Steerable Guidewires.
| Device ID | K974560 |
| 510k Number | K974560 |
| Device Name: | CORDIS VANGUARD STEERABLE GUIDEWIRES |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Dennis Griffin |
| Correspondent | Dennis Griffin 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 | 1997-12-05 |
| Decision Date | 1998-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056042 | K974560 | 000 |
| 20705032055922 | K974560 | 000 |
| 20705032055915 | K974560 | 000 |