The following data is part of a premarket notification filed by Flowcardia, Inc. with the FDA for Flowcardia Flowmater Injector, Model Inj 100.
| Device ID | K090621 |
| 510k Number | K090621 |
| Device Name: | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 |
| Classification | Injector And Syringe, Angiographic |
| 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 | DXT |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-09 |
| Decision Date | 2009-06-19 |
| Summary: | summary |