The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordius Endeavor (various).
Device ID | K972110 |
510k Number | K972110 |
Device Name: | CORDIUS ENDEAVOR (VARIOUS) |
Classification | Catheter, Continuous Flush |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Ariel Mactavish |
Correspondent | Ariel Mactavish CORDIS CORP. 14201 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 | 1997-06-05 |
Decision Date | 1997-08-14 |
Summary: | summary |