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FDA 510(k) Applications Submitted by David Worrell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K991314
04/16/1999
COAGULOOP
AMERICAN MEDICAL SYSTEMS, INC.
K072301
08/17/2007
5MM PROTEGE EVERFLEX SELF EXPANDING BILIARY STENT SYSTEM, MODEL PRP35-05
EV3 INC.
K082579
09/05/2008
EVERCROSS .035 OTW PTA DILATATION CATHETER
EV3 INC.
K062809
09/19/2006
ADMIRAL XTREME PTA CATHETER
INVATEC INNOVATIVE TECHNOLOGIES
K082854
09/29/2008
NANOCORSS .014 OTW PTA DILATATION CATHETER
EV3 INC.
K023516
10/21/2002
MONARC SLING SYSTEM
AMERICAN MEDICAL SYSTEMS, INC.
K063204
10/23/2006
SPIDERFX EMBOLIC PROTECTION DEVICE
EV3 INC
K063785
12/21/2006
SPIDERFX EMBOLIC PROTECTION DEVICE
EV3 INC
K103322
11/12/2010
EVERCROSS 0.035 OTW PTA DILATION CATHETER
EV3 INC
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