The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis M3 Pta Dilatation Catheter.
| Device ID | K003920 |
| 510k Number | K003920 |
| Device Name: | CORDIS M3 PTA DILATATION CATHETER |
| Classification | Catheter, Percutaneous |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Charles (chuck) J Ryan |
| Correspondent | Charles (chuck) J Ryan CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-19 |
| Decision Date | 2001-06-15 |