The following data is part of a premarket notification filed by Flowcardia Inc with the FDA for The Crosser Catheter, Model Cr1100 And System Electronics, Model Fg1002-02.
| Device ID | K062868 |
| 510k Number | K062868 |
| Device Name: | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 |
| Classification | Catheter, Percutaneous |
| Applicant | FLOWCARDIA INC 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Contact | Dustin Michaels |
| Correspondent | Dustin Michaels FLOWCARDIA INC 745 N. PASTORIA AVE. Sunnyvale, CA 94085 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-25 |
| Decision Date | 2007-01-19 |
| Summary: | summary |