The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Modification To Envoy And Vista Brite Tip.
| Device ID | K021593 |
| 510k Number | K021593 |
| Device Name: | MODIFICATION TO ENVOY AND VISTA BRITE TIP |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Stephen M Enos |
| Correspondent | Stephen M Enos CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-15 |
| Decision Date | 2002-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032020005 | K021593 | 000 |
| 20705032020180 | K021593 | 000 |
| 20705032020098 | K021593 | 000 |
| 20705032075067 | K021593 | 000 |
| 20705032042977 | K021593 | 000 |
| 20705032028766 | K021593 | 000 |
| 20705032028575 | K021593 | 000 |
| 20705032074299 | K021593 | 000 |
| 20705032067468 | K021593 | 000 |
| 20705032065136 | K021593 | 000 |
| 20705032063781 | K021593 | 000 |
| 20705032042939 | K021593 | 000 |
| 20705032041833 | K021593 | 000 |
| 20705032041734 | K021593 | 000 |
| 20705032031605 | K021593 | 000 |
| 20705032031315 | K021593 | 000 |
| 20705032028544 | K021593 | 000 |
| 20705032020456 | K021593 | 000 |
| 20705032020548 | K021593 | 000 |
| 20705032020579 | K021593 | 000 |
| 20705032019993 | K021593 | 000 |
| 20705032019986 | K021593 | 000 |
| 20705032019979 | K021593 | 000 |
| 20705032019962 | K021593 | 000 |
| 20705032019955 | K021593 | 000 |
| 20705032019948 | K021593 | 000 |
| 20705032019931 | K021593 | 000 |
| 20705032019924 | K021593 | 000 |
| 20705032019917 | K021593 | 000 |
| 20705032019900 | K021593 | 000 |
| 20705032019887 | K021593 | 000 |
| 20705032019870 | K021593 | 000 |
| 20705032019863 | K021593 | 000 |
| 20705032019856 | K021593 | 000 |
| 20705032021002 | K021593 | 000 |
| 20705032020944 | K021593 | 000 |
| 10705032101011 | K021593 | 000 |