The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Maxi Ld Large Diameter Balloon Dilatation Catheter, Cordis Maxi Ld Pta Balloon Dilation Catheter.
| Device ID | K023907 |
| 510k Number | K023907 |
| Device Name: | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER |
| Classification | Dilator, Esophageal |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Donna Marshall |
| Correspondent | Donna Marshall CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-25 |
| Decision Date | 2002-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032002728 | K023907 | 000 |
| 20705032002711 | K023907 | 000 |
| 20705032002704 | K023907 | 000 |
| 20705032002698 | K023907 | 000 |