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 |
| 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 |
| 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 |
| 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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