The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Opta5 Pta Balloon Catheter, Powerflex Pta Balloon Catheter, Ultra-thin Diamond Balloon Catheter, Palmaz Balloon Expandab.
| Device ID | K972825 |
| 510k Number | K972825 |
| Device Name: | OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Mirjam Barboza |
| Correspondent | Mirjam Barboza CORDIS CORP. 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-09 |
| Decision Date | 1997-10-07 |
| Summary: | summary |