The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Vista Brite Tip Catheters.
| Device ID | K963962 |
| 510k Number | K963962 |
| Device Name: | VISTA BRITE TIP CATHETERS |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Katherine Trevisol |
| Correspondent | Katherine Trevisol CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-02 |
| Decision Date | 1997-05-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032017807 | K963962 | 000 |
| 20705032017272 | K963962 | 000 |
| 20705032017173 | K963962 | 000 |
| 20705032017036 | K963962 | 000 |
| 20705032017012 | K963962 | 000 |
| 20705032069936 | K963962 | 000 |
| 20705032063989 | K963962 | 000 |
| 20705032043370 | K963962 | 000 |
| 20705032031629 | K963962 | 000 |
| 20705032031421 | K963962 | 000 |
| 20705032031339 | K963962 | 000 |
| 20705032029404 | K963962 | 000 |
| 20705032042120 | K963962 | 000 |
| 20705032017302 | K963962 | 000 |
| 20705032017418 | K963962 | 000 |
| 20705032017432 | K963962 | 000 |
| 20705032017784 | K963962 | 000 |
| 20705032017678 | K963962 | 000 |
| 20705032017630 | K963962 | 000 |
| 20705032017616 | K963962 | 000 |
| 20705032017593 | K963962 | 000 |
| 20705032017562 | K963962 | 000 |
| 20705032017548 | K963962 | 000 |
| 20705032017531 | K963962 | 000 |
| 20705032017500 | K963962 | 000 |
| 20705032017494 | K963962 | 000 |
| 20705032017463 | K963962 | 000 |
| 20705032017449 | K963962 | 000 |
| 20705032029435 | K963962 | 000 |