Flowcardia, Inc. - FDA 510(k) Cleared Devices
Recent clearances: THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200, FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100, THE CROSSER 14 OTW CATHETER, MODEL CRU014
11
Total
11
Cleared
0
Denied
FDA 510(k) Regulatory Record - Flowcardia, Inc. Cardiovascular ✕
11 devices
Cleared
Feb 17, 2010
THE CROSSER S6 CATHETER, THE CROSSER SYSTEM ELECTRONICS, MODEL CRUS6, GEN200
Cardiovascular
211d
Cleared
Jun 19, 2009
FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100
Cardiovascular
102d
Cleared
May 29, 2009
THE CROSSER 14 OTW CATHETER, MODEL CRU014
Cardiovascular
30d
Cleared
May 15, 2009
MODIFICATION TO THE CROSSER SYSTEM
Cardiovascular
28d
Cleared
Jul 25, 2008
MICROSHEATH LP AND LP-AT
Cardiovascular
121d
Cleared
Jun 20, 2008
CROSSER LP SYSTEM
Cardiovascular
94d
Cleared
Jan 11, 2008
MICROSHEATH XL CATHETERS
Cardiovascular
51d
Cleared
Dec 07, 2007
THE CROSSER SYSTEM
Cardiovascular
70d
Cleared
Jan 19, 2007
THE CROSSER CATHETER, MODEL CR1100 AND SYSTEM ELECTRONICS, MODEL FG1002-02
Cardiovascular
116d
Cleared
Oct 31, 2005
VP SHEATH
Cardiovascular
138d
Cleared
Jul 15, 2005
VP WIRE GW140ST (.014 165CM, STANDAR), MODEL GW140ST
Cardiovascular
80d