The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Cordis Powerflex Plus Pta Balloon Catheter.
| Device ID | K971516 |
| 510k Number | K971516 |
| Device Name: | CORDIS POWERFLEX PLUS PTA BALLOON CATHETER |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| 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 | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-28 |
| Decision Date | 1997-07-23 |
| Summary: | summary |