Flowcardia, Inc.
Medical device manufacturer in Sunnyvale, CA.
11510(k) clearances
0PMA approvals
1recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K092175 | The Crosser S6 Catheter, the Crosser System Electronics, Model CRUS6, GEN200PDU · Traditional | 02/17/2010SE |
| K090621 | Flowcardia Flowmater Injector, Model Inj 100DXT · Traditional | 06/19/2009SE |
| K091254 | The Crosser 14 Otw Catheter, Model CRU014DQY · Special | 05/29/2009SE |
| K091119 | Modification to the Crosser SystemPDU · Special | 05/15/2009SE |
| K080849 | Microsheath LP and Lp-AtDQY · Traditional | 07/25/2008SE |
| K080765 | Crosser LP SystemDQX · Traditional | 06/20/2008SE |
| K073289 | Microsheath XL CathetersDQY · Traditional | 01/11/2008SE |
| K072776 | The Crosser SystemPDU · Traditional | 12/07/2007SE |
| K062868 | The Crosser Catheter, Model CR1100 and System Electronics, Model FG1002-02DQY · Traditional | 01/19/2007SE |
| K051580 | VP SheathDQY · Traditional | 10/31/2005SE |
| K051062 | VP Wire GW140ST (.014 165CM, Standar), Model GW140ST; VP Wire GW140SO (.014 165CM, Soft)…DQX · Traditional | 07/15/2005SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-0938-2011 | Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia…Mislabeled expiration date: Some units were mislabeled with a three year shelf life, but the product is… | 01/09/2009Terminated |