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 |
| 10705032010276 | K962746 | 000 |
| 10705032010283 | K962746 | 000 |
| 10705032010290 | K962746 | 000 |
| 10705032010306 | K962746 | 000 |
| 10705032010313 | K962746 | 000 |
| 10705032010320 | K962746 | 000 |
| 10705032031790 | K962746 | 000 |
| 10705032047173 | K962746 | 000 |
| 10705032047012 | K962746 | 000 |
| 10705032047180 | K962746 | 000 |
| 10705032047203 | K962746 | 000 |
| 10705032047340 | K962746 | 000 |
| 10705032047357 | K962746 | 000 |
| 10705032010269 | K962746 | 000 |