The following data is part of a premarket notification filed by Cordis Corporation with the FDA for Saber .035 Pta Dilatation Catheter.
| Device ID | K201333 |
| 510k Number | K201333 |
| Device Name: | SABER .035 PTA Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Cordis Corporation 14201 N.W. 60TH AVE. Miami Lakes, FL 33014 |
| Contact | Kyungyoon Kang |
| Correspondent | Kyungyoon Kang Cordis Corporation 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 | 2020-05-19 |
| Decision Date | 2020-09-11 |