FDA 510(k) Applications Submitted by BOSTON SCIENTIFIC, TARGET

FDA 510(k) Number Submission Date Device Name Applicant
K022357 07/19/2002 TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 BOSTON SCIENTIFIC, TARGET
K013789 11/14/2001 EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 BOSTON SCIENTIFIC, TARGET
K993292 10/01/1999 BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER BOSTON SCIENTIFIC, TARGET
K010707 03/09/2001 ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 BOSTON SCIENTIFIC, TARGET
K022860 08/28/2002 ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC, TARGET
K030475 02/13/2003 GDC STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET
K001083 04/04/2000 GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 BOSTON SCIENTIFIC, TARGET
K031168 04/14/2003 MATRIX STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET
K021494 05/09/2002 GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 BOSTON SCIENTIFIC, TARGET
K002181 07/19/2000 GDC ULTRASOFT COIL BOSTON SCIENTIFIC, TARGET
K991139 04/05/1999 GUGLIELMI DETACHABLE (GDC) BOSTON SCIENTIFIC, TARGET
K031049 04/02/2003 GUGLIELMI DETACHABLE COIL (GDC) BOSTON SCIENTIFIC, TARGET
K993417 10/01/1999 GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) BOSTON SCIENTIFIC, TARGET
K993418 10/01/1999 FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL BOSTON SCIENTIFIC, TARGET
K993415 10/01/1999 GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 BOSTON SCIENTIFIC, TARGET
K010853 03/21/2001 GUIDER SOFTIP GUIDING CATHETER XF 5F BOSTON SCIENTIFIC, TARGET
K994155 12/09/1999 EXCELSIOR 1018 MICROCATHETER BOSTON SCIENTIFIC, TARGET
K012985 09/06/2001 MATRIX DETACHABLE COILS BOSTON SCIENTIFIC, TARGET
K014109 12/14/2001 IN-TIME RETRIEVAL DEVICE BOSTON SCIENTIFIC, TARGET


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