The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Steerable Guidewire.
Device ID | K873403 |
510k Number | K873403 |
Device Name: | CORDIS STEERABLE GUIDEWIRE |
Classification | Wire, Guide, Catheter |
Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
Contact | Hennemann, Phd |
Correspondent | Hennemann, Phd CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
Product Code | DQX |
CFR Regulation Number | 870.1330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-08-24 |
Decision Date | 1988-03-22 |