The following data is part of a premarket notification filed by Cordis Neurovascular, Inc. with the FDA for Transit Infusion Catheter.
Device ID | K952874 |
510k Number | K952874 |
Device Name: | TRANSIT INFUSION CATHETER |
Classification | Catheter, Continuous Flush |
Applicant | CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Marlene Wright Valenti |
Correspondent | Marlene Wright Valenti CORDIS NEUROVASCULAR, INC. 14740 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | KRA |
CFR Regulation Number | 870.1210 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-05-23 |
Decision Date | 1995-08-21 |