The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Steerable Guidewire.
Device ID | K923134 |
510k Number | K923134 |
Device Name: | CORDIS STEERABLE GUIDEWIRE |
Classification | Wire, Guide, Catheter |
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 | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-06-29 |
Decision Date | 1992-10-26 |