The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Vista Brite Tip Guiding Catheters.
Device ID | K972978 |
510k Number | K972978 |
Device Name: | VISTA BRITE TIP GUIDING 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 | 1997-08-11 |
Decision Date | 1997-10-21 |
Summary: | summary |