The following data is part of a premarket notification filed by Cordis Corp. with the FDA for 4f Nylex Angiographic Catheter.
Device ID | K962759 |
510k Number | K962759 |
Device Name: | 4F NYLEX ANGIOGRAPHIC CATHETER |
Classification | Catheter, Intravascular, Diagnostic |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Jodi L Frasier |
Correspondent | Jodi L Frasier CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Product Code | DQO |
CFR Regulation Number | 870.1200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-07-16 |
Decision Date | 1996-10-10 |
Summary: | summary |