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Peripheral Systems Group

FDA 510(k) & PMA Approved Devices — 17 products

Total Devices17
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K940804 SMARTNEEDLE VASCULAR ACCESS SYSTEM, MODIFICATIONITX1994-06-10 View
510(k) K934433 VANTAGE DIALTAION CATHETERLIT1993-12-09 View
510(k) K932777 SMARTNEEDLE(R) OVER-THE-NEEDLE CATHETERITX1993-10-07 View
510(k) K931327 PSG DIRECTIONAL HYDROPHILIC GUIDE WIREDQX1993-07-14 View
510(k) K915554 HI-TORQUE SPORT-T(TM) GUIDE WIREDQX1993-02-09 View
510(k) K914979 EDM(R) INFUSION CATHETERKRA1992-09-16 View
510(k) K913941 PSG(TM) 20 GUAGE DOPPLER NEEDLEITX1992-02-27 View
510(k) K915168 PROFLEX 5LIT1992-02-19 View
510(k) K913477 APEX(TM) PROSTATIC BALLOON DILATION CATHETERKOE1991-12-27 View
510(k) K913746 SMARTNEEDLE(TM) VASCULAR ACCESS SYSTEMITX1991-12-17 View
510(k) K904984 ADVANCE 418(TM)LIT1991-04-12 View
510(k) K904959 PSG HEMOSTATIC CONTROL VALVEDQO1990-12-17 View
510(k) K903625 DOPPLER NEEDLE AND FLOW MONITORDPW1990-11-07 View
510(k) K895179 ACCESSOR PERIPHERAL DILATING GUIDE WIRELIT1990-02-28 View
510(k) K894944 BALLOON DILATATION CATHETERLIT1990-01-19 View
510(k) K895146 GUIDING CATHETERDQO1990-01-19 View
510(k) K895932 PSG(TM) EDM(TM) INFUSION CATHETERDQY1990-01-04 View
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