The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for The Crosser System.
| Device ID | K072776 |
| 510k Number | K072776 |
| Device Name: | THE CROSSER SYSTEM |
| Classification | Catheter For Crossing Total Occlusions |
| 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 | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-28 |
| Decision Date | 2007-12-07 |
| Summary: | summary |