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.
| Device ID | K993720 |
| 510k Number | K993720 |
| Device Name: | CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER |
| Classification | Dilator, Esophageal |
| 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 | KNQ |
| CFR Regulation Number | 876.5365 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-03 |
| Decision Date | 2000-01-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20705032002728 | K993720 | 000 |
| 20705032002537 | K993720 | 000 |
| 20705032002520 | K993720 | 000 |
| 20705032002506 | K993720 | 000 |
| 20705032002490 | K993720 | 000 |
| 20705032002476 | K993720 | 000 |
| 20705032002469 | K993720 | 000 |
| 20705032002452 | K993720 | 000 |
| 20705032002445 | K993720 | 000 |
| 20705032002438 | K993720 | 000 |
| 20705032002421 | K993720 | 000 |
| 20705032002346 | K993720 | 000 |
| 20705032002117 | K993720 | 000 |
| 20705032002551 | K993720 | 000 |
| 20705032002568 | K993720 | 000 |
| 20705032002575 | K993720 | 000 |
| 20705032002711 | K993720 | 000 |
| 20705032002704 | K993720 | 000 |
| 20705032002698 | K993720 | 000 |
| 20705032002667 | K993720 | 000 |
| 20705032002650 | K993720 | 000 |
| 20705032002643 | K993720 | 000 |
| 20705032002636 | K993720 | 000 |
| 20705032002629 | K993720 | 000 |
| 20705032002612 | K993720 | 000 |
| 20705032002605 | K993720 | 000 |
| 20705032002599 | K993720 | 000 |
| 20705032002582 | K993720 | 000 |
| 20705032002100 | K993720 | 000 |