The following data is part of a premarket notification filed by Cordis Europa, N.v. with the FDA for Cordis Amila Percutaneous Transluminal Angioplasty (pta) Balloon Dilatation Catheter.
| Device ID | K063563 |
| 510k Number | K063563 |
| Device Name: | CORDIS AMILA PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON DILATATION CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | CORDIS EUROPA, N.V. 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Contact | Joan Martin |
| Correspondent | Joan Martin CORDIS EUROPA, N.V. 7 POWDER HORN DRIVE Warren, NJ 07059 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-28 |
| Decision Date | 2007-03-07 |
| Summary: | summary |