Company ยท US
Boston Scientific, Target
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2003. Name variants (Inc, Corp, punctuation) are merged.
19510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 1, 2003 | K031049 | GUGLIELMI DETACHABLE COIL (GDC) Boston Scientific, Target | HCG |
| May 14, 2003 | K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target | HCG |
| Mar 14, 2003 | K030475 | GDC STRETCH RESISTANT DETACHABLE COIL Boston Scientific, Target | HCG |
| Nov 21, 2002 | K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific, Target | ITX |
| Oct 16, 2002 | K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPPY GUIDEWIRE, MODEL 46-815 Boston Scientific, Target | DQX |
| Jun 6, 2002 | K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 Boston Scientific, Target | HCG |
| Mar 12, 2002 | K014109 | IN-TIME RETRIEVAL DEVICE Boston Scientific, Target | MMX |
| Jan 31, 2002 | K012985 | MATRIX DETACHABLE COILS Boston Scientific, Target | HCG |
| Dec 6, 2001 | K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181, 168189 Boston Scientific, Target | DQY |
| Apr 18, 2001 | K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F Boston Scientific, Target | DQY |
| Mar 29, 2001 | K010707 | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 Boston Scientific, Target | DQO |
| Aug 11, 2000 | K002181 | GDC ULTRASOFT COIL Boston Scientific, Target | HCG |
| Aug 3, 2000 | K994155 | EXCELSIOR 1018 MICROCATHETER Boston Scientific, Target | KRA |
| May 3, 2000 | K001083 | GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUPPLY : 451006-4; CABLES: 451102-4 Boston Scientific, Target | HCG |
| Mar 23, 2000 | K993292 | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER Boston Scientific, Target | MJN |
| Jan 21, 2000 | K993418 | FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL Boston Scientific, Target | HCG |
| Jan 21, 2000 | K993417 | GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-18 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC) Boston Scientific, Target | HCG |
| Jan 21, 2000 | K993415 | GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2-DIAMETER STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-1 Boston Scientific, Target | HCG |
| Dec 22, 1999 | K991139 | GUGLIELMI DETACHABLE (GDC) Boston Scientific, Target | HCG |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 5, 2007 | Boston Scientific Target Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806,
Boston Scientific Target, Fremont, CA 94538 Terminated |
DQX | K931584 |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 100cm usable length, Material Number (UPN) M003101420, Catalog Number: 10142, Single-use Disposable Guide Catheters Terminated |
DQY | K980453 |
| Nov 24, 2007 | Boston Scientific Target Boston Scientific 6F Guider Softip XF Guiding Catheter, 6 French, 40 degree angle, 90cm usable length, Material Number (UPN) H965100420, Catalog Number : 10042, Made in USA: 5905 Nathan Lane, Plymout Terminated |
DQY | K980453 |
| Mar 29, 2007 | Boston Scientific Target Matrix2 Detachable Coils, vascular embolization device.
Catalog Number: 497204SR, UPN: M003497204SR0,
Catalog Number: 494203, UPN: M0034942030, Distributed and Manufactured by Boston Scientific Co Terminated |
HCG | K050700 |
| Feb 1, 2007 | Boston Scientific Target Boston Scientific brand iLab Ultrasound Imaging System, for intravascular use;
Model Number(s): iLab120lNS, iLab2401NS,
Distributed by and Manufactured by:
Boston Scientific Corporation IVUS, Tech Terminated |
DQO | K051679 |
| Nov 14, 2006 | Boston Scientific Target Boston Scientific brand Renegade 18 Fiber braided microcatheter, Catalog #: 18257, UPN: M001182570 Terminated |
KRA | K973645 |
| May 23, 2006 | Boston Scientific Target Boston Scientific brand Pivot Steerable Microcatheter, 1.9F/2.4F,
Catalog #: 1721, Universal Product Number: M00317210,
Product is Manufactured by: Boston Scientific - Precision Vascular, 2405 West Terminated |
KRA | K050630 |
| Apr 22, 2006 | Boston Scientific Target iLab Utrasound Imaging System, software controlled Imaging Catheter. Terminated |
DQO | K051679 |