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 |