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FDA 510(k) Applications Submitted by LAURA J LIND
FDA 510(k) Number
Submission Date
Device Name
Applicant
K130911
04/02/2013
RAPIDCROSS PTA RAPID EXCHANGE BALLOON DILATATION CATHETER
EV3 INC.
K141118
04/30/2014
NANOCROSS EITE 0.014 OVER-THE-WIRE PTA BALLOON DILATATION CATHETER
EV3 INC
K121667
06/06/2012
NC QUANTUM APEX PTCA DILATATION CATHETER (MONORAIL)
BOSTON SCIENTIFIC CORP.
K123544
11/19/2012
RAPIDCROSS PTA RAPID EXCHANGE, BALLOON DILATATION CATHETER
EV3 INC
K151305
05/18/2015
SenSmart Model 8203CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg, SenSmart Model 820CA Regional Oximetry Sensor (Adult/Pediatric, >40 kg)
NONIN MEDICAL INC.
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