The following data is part of a premarket notification filed by Curatia Medical Co. with the FDA for Xcess Guiding Catheter.
| Device ID | K180797 |
| 510k Number | K180797 |
| Device Name: | Xcess Guiding Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Curatia Medical Co. 3227 Kifer Road Santa Clara, CA 95051 |
| Contact | Jessica Chiu |
| Correspondent | Breanne Butler JCQ Consulting 11218 Zest Court NE Blaine, MN 55449 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-27 |
| Decision Date | 2018-12-14 |
| Summary: | summary |