The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Cinch(tm) Steer Guidewire Exten W/slx Coat.
Device ID | K902612 |
510k Number | K902612 |
Device Name: | CORDIS CINCH(TM) STEER GUIDEWIRE EXTEN W/SLX COAT |
Classification | Wire, Guide, Catheter |
Applicant | CORDIS CORP. P.O. BOX 025700 Miami, FL 33102 |
Contact | Trevisol-cappelli |
Correspondent | Trevisol-cappelli 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 | 1990-06-13 |
Decision Date | 1990-12-03 |