Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific, Target — Predicate Candidate Screening
19 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
88 daysmedian FDA review time
238 days90th percentile
19clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K031049 | GUGLIELMI DETACHABLE COIL (GDC) | Boston Scientific, Target | 2003-08-01 | 121 | 0 |
| K031168 | MATRIX STRETCH RESISTANT DETACHABLE COIL | Boston Scientific, Target | 2003-05-14 | 30 | 10 |
| K030475 | GDC STRETCH RESISTANT DETACHABLE COIL | Boston Scientific, Target | 2003-03-14 | 29 | 1 |
| K022860 | ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Boston Scientific, Target | 2002-11-21 | 85 | 0 |
| K022357 | TRANSEND 300 ES GUIDEWIRE, MODEL 46-814 & TRANSEND 300 FLOPP | Boston Scientific, Target | 2002-10-16 | 89 | 0 |
| K021494 | GDC POWER SUPPLY, MODEL GDC POWER SUPPLY: 451007-4 | Boston Scientific, Target | 2002-06-06 | 28 | 0 |
| K014109 | IN-TIME RETRIEVAL DEVICE | Boston Scientific, Target | 2002-03-12 | 88 | 0 |
| K012985 | MATRIX DETACHABLE COILS | Boston Scientific, Target | 2002-01-31 | 147 | 10 |
| K013789 | EXCELSIOR SL-10 MICROCATHETER, MODELS 168581, 168381, 168181 | Boston Scientific, Target | 2001-12-06 | 22 | 1 |
| K010853 | GUIDER SOFTIP GUIDING CATHETER XF 5F | Boston Scientific, Target | 2001-04-18 | 28 | 16 |
| K010707 | ATLANTIS SR PLUS CORONARY IMAGING CATHETER, MODEL 35975 | Boston Scientific, Target | 2001-03-29 | 20 | 0 |
| K002181 | GDC ULTRASOFT COIL | Boston Scientific, Target | 2000-08-11 | 23 | 0 |
| K994155 | EXCELSIOR 1018 MICROCATHETER | Boston Scientific, Target | 2000-08-03 | 238 | 0 |
| K001083 | GUGLIELMI DETACHABLE COIL AND POWER SUPPLY, MODELS POWER SUP | Boston Scientific, Target | 2000-05-03 | 29 | 0 |
| K993292 | BOSTON SCIENTIFIC/TARGET SENTRY OCCLUSION BALLOON CATHETER | Boston Scientific, Target | 2000-03-23 | 174 | 0 |
| K993418 | FIBERED GDC-18 VORTX SHAPE GUGLIELMI DETACHABLE COIL | Boston Scientific, Target | 2000-01-21 | 112 | 1 |
| K993417 | GDC-10 GUGLIELMI DETACHABLE COIL (GDC) (3D SHAPE GDC), GDC-1 | Boston Scientific, Target | 2000-01-21 | 112 | 0 |
| K993415 | GDC-10 STRETCH RESISTANT GUGLIELMI DETACHABLE COIL, GDC-10 2 | Boston Scientific, Target | 2000-01-21 | 112 | 0 |
| K991139 | GUGLIELMI DETACHABLE (GDC) | Boston Scientific, Target | 1999-12-22 | 261 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda