The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Cxi Support Catheter.
Device ID | K160884 |
510k Number | K160884 |
Device Name: | CXI Support Catheter |
Classification | Catheter, Continuous Flush |
Applicant | COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
Contact | Daniel J. Corbin |
Correspondent | Daniel J. Corbin COOK INCORPORATED 750 DANIELS WAY Bloomington, IN 47404 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-03-31 |
Decision Date | 2016-11-22 |
Summary: | summary |