The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Amiia .014 Pta Balloon Catheter.
| Device ID | K050645 |
| 510k Number | K050645 |
| Device Name: | CORDIS AMIIA .014 PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Contact | Karen Wilk |
| Correspondent | Karen Wilk CORDIS CORP. 7 POWDER HORN DR. Warren, NJ 07059 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-03-14 |
| Decision Date | 2005-04-01 |
| Summary: | summary |