The following data is part of a premarket notification filed by Curatia Medical with the FDA for Vela Rx Pta Balloon Dilatation Catheter.
| Device ID | K171290 |
| 510k Number | K171290 |
| Device Name: | Vela RX PTA Balloon Dilatation Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Curatia Medical 3227 Kifer Road Santa Clara, CA 95051 |
| Contact | Jessica Chiu |
| Correspondent | Bill Jacqmein JCQ Consulting 11218 Zest Court Blaine, MN 55449 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-02 |
| Decision Date | 2017-07-19 |
| Summary: | summary |