The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Avanti Trans-radial Catheter Sheath Introducer Kit.
Device ID | K962746 |
510k Number | K962746 |
Device Name: | CORDIS AVANTI TRANS-RADIAL CATHETER SHEATH INTRODUCER KIT |
Classification | Introducer, Catheter |
Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
Contact | Marlene W Valenti |
Correspondent | Marlene W Valenti 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 | 1996-07-15 |
Decision Date | 1996-10-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10705032047579 | K962746 | 000 |
10705032047357 | K962746 | 000 |
10705032047340 | K962746 | 000 |
10705032047203 | K962746 | 000 |
10705032047180 | K962746 | 000 |
10705032047012 | K962746 | 000 |