The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis St Steerable Guidewire.
| Device ID | K963214 |
| 510k Number | K963214 |
| Device Name: | CORDIS ST STEERABLE GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Lisa Wells |
| Correspondent | Lisa Wells 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 | 1996-08-16 |
| Decision Date | 1996-11-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056080 | K963214 | 000 |
| 20705032056073 | K963214 | 000 |
| 20705032056066 | K963214 | 000 |
| 20705032056059 | K963214 | 000 |