Company ยท US
Flowcardia, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2010. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 17, 2010 | K092175 | THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 Flowcardia, Inc. | PDU |
| Jun 19, 2009 | K090621 | FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 Flowcardia, Inc. | DXT |
| May 29, 2009 | K091254 | THE CROSSER 14 OTW CATHETER, MODEL CRU014 Flowcardia, Inc. | DQY |
| May 15, 2009 | K091119 | MODIFICATION TO THE CROSSER SYSTEM Flowcardia, Inc. | PDU |
| Jul 25, 2008 | K080849 | MICROSHEATH LP AND LP-AT Flowcardia, Inc. | DQY |
| Jun 20, 2008 | K080765 | CROSSER LP SYSTEM Flowcardia, Inc. | DQX |
| Jan 11, 2008 | K073289 | MICROSHEATH XL CATHETERS Flowcardia, Inc. | DQY |
| Dec 7, 2007 | K072776 | THE CROSSER SYSTEM Flowcardia, Inc. | PDU |
| Jan 19, 2007 | K062868 | THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02 Flowcardia, Inc. | DQY |
| Oct 31, 2005 | K051580 | VP SHEATH Flowcardia, Inc. | DQY |
| Jul 15, 2005 | K051062 | VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO Flowcardia, Inc. | DQX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2011 | Flowcardia Inc. Crosser 14S Catheter, Catalog/REF CRU14S, Lot number 5053 manufactured by Flowcardia Inc, Sunnyvale, CA
Intended use: Catheter for use in surgery. Terminated |
DQY | K072776 |