The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Saber .035 Percutaneous Transluminal Angioplasty (pta) Dilatation Catheter.
| Device ID | K210626 |
| 510k Number | K210626 |
| Device Name: | SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, FL 33014 |
| Contact | Wai Morgan |
| Correspondent | Wai Morgan Cordis Corporation 14201 N.W. 60th Avenue 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 | 2021-03-02 |
| Decision Date | 2021-04-23 |