FDA 510(k) Applications Submitted by FLOWCARDIA, INC.
FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
K090621 |
03/09/2009 |
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 |
FLOWCARDIA, INC. |
K080765 |
03/18/2008 |
CROSSER LP SYSTEM |
FLOWCARDIA, INC. |
K080849 |
03/26/2008 |
MICROSHEATH LP AND LP-AT |
FLOWCARDIA, INC. |
K091119 |
04/17/2009 |
MODIFICATION TO THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
K091254 |
04/29/2009 |
THE CROSSER 14 OTW CATHETER, MODEL CRU014 |
FLOWCARDIA, INC. |
K092175 |
07/21/2009 |
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200 |
FLOWCARDIA, INC. |
K072776 |
09/28/2007 |
THE CROSSER SYSTEM |
FLOWCARDIA, INC. |
K073289 |
11/21/2007 |
MICROSHEATH XL CATHETERS |
FLOWCARDIA, INC. |
K051062 |
04/26/2005 |
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST; VP WIRE GW140SO (.014 165CM, SOFT) MODEL GW140SO |
FLOWCARDIA, INC. |
K051580 |
06/15/2005 |
VP SHEATH |
FLOWCARDIA, INC. |
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