The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Marker Wire Steerable Guidewire (stabilizer With Radiopaque Markers) And (wizdom With Radiopaque Markers).
| Device ID | K962765 |
| 510k Number | K962765 |
| Device Name: | CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS) |
| 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 | 1996-07-16 |
| Decision Date | 1997-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032056394 | K962765 | 000 |
| 20705032056387 | K962765 | 000 |
| 20705032056370 | K962765 | 000 |
| 20705032056363 | K962765 | 000 |