The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Wizdom Steerable Guidewire.
| Device ID | K953760 |
| 510k Number | K953760 |
| Device Name: | CORDIS WIZDOM STEERABLE GUIDEWIRE |
| 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 | 1995-08-11 |
| Decision Date | 1995-11-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056516 | K953760 | 000 |
| 20705032056493 | K953760 | 000 |
| 20705032056318 | K953760 | 000 |
| 20705032056301 | K953760 | 000 |
| 20705032056240 | K953760 | 000 |
| 20705032056202 | K953760 | 000 |
| 20705032056165 | K953760 | 000 |
| 20705032056141 | K953760 | 000 |