The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Cath Sheath Intro Syst Plus W/unistasis Val.
Device ID | K913801 |
510k Number | K913801 |
Device Name: | CORDIS CATH SHEATH INTRO SYST PLUS W/UNISTASIS VAL |
Classification | Introducer, Catheter |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Mirjam Barboza |
Correspondent | Mirjam Barboza CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DYB |
CFR Regulation Number | 870.1340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-08-26 |
Decision Date | 1991-10-16 |