The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for The Crosser 14 Otw Catheter, Model Cru014.
| Device ID | K091254 |
| 510k Number | K091254 |
| Device Name: | THE CROSSER 14 OTW CATHETER, MODEL CRU014 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-29 |
| Decision Date | 2009-05-29 |
| Summary: | summary |