Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Boston Scientific Scimed, Inc. — Predicate Candidate Screening
35 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
236 days90th percentile
35clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | Boston Scientific Scimed, Inc. | 2004-07-23 | 28 | 0 |
| K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE | Boston Scientific Scimed, Inc. | 2003-05-21 | 84 | 4 |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUN | Boston Scientific Scimed, Inc. | 2003-01-06 | 28 | 0 |
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | Boston Scientific Scimed, Inc. | 2002-08-08 | 72 | 23 |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS D | Boston Scientific Scimed, Inc. | 2002-07-09 | 29 | 1 |
| K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONOR | Boston Scientific Scimed, Inc. | 2001-10-24 | 62 | 0 |
| K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | Boston Scientific Scimed, Inc. | 2001-08-17 | 32 | 0 |
| K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, | Boston Scientific Scimed, Inc. | 2000-09-06 | 183 | 0 |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVE | Boston Scientific Scimed, Inc. | 2000-06-05 | 154 | 1 |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | Boston Scientific Scimed, Inc. | 2000-04-21 | 28 | 1 |
| K993232 | WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY S | Boston Scientific Scimed, Inc. | 1999-12-30 | 94 | 0 |
| K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS | Boston Scientific Scimed, Inc. | 1999-08-23 | 61 | 1 |
| K982005 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-09-02 | 86 | 0 |
| K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1998-08-11 | 187 | 19 |
| K982077 | SELECTOR DIAGNOSTIC CATHETER | Boston Scientific Scimed, Inc. | 1998-08-11 | 60 | 0 |
| K982184 | WALLSTENT ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-07-21 | 29 | 0 |
| K981413 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1998-05-13 | 23 | 0 |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1998-04-03 | 80 | 0 |
| K980163 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRAC | Boston Scientific Scimed, Inc. | 1998-03-13 | 56 | 1 |
| K972512 | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASC | Boston Scientific Scimed, Inc. | 1998-02-12 | 220 | 0 |
| K964119 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1997-04-28 | 195 | 6 |
| K964121 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-12-04 | 50 | 1 |
| K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | Boston Scientific Scimed, Inc. | 1996-11-19 | 181 | 0 |
| K961499 | LAGUNA SOFTIP DIAGNOSTIC CATHETERS | Boston Scientific Scimed, Inc. | 1996-10-17 | 182 | 0 |
| K961507 | WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | 82 | 0 |
| K954290 | WALLSTENT ENTERAL ENDOPROTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | 300 | 0 |
| K961296 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1996-07-10 | 97 | 1 |
| K961262 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDO | Boston Scientific Scimed, Inc. | 1996-05-10 | 38 | 0 |
| K945494 | WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS | Boston Scientific Scimed, Inc. | 1995-03-03 | 115 | 1 |
| K943622 | SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER | Boston Scientific Scimed, Inc. | 1994-11-30 | 126 | 0 |
| K940396 | WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) | Boston Scientific Scimed, Inc. | 1994-10-03 | 249 | 0 |
| K940395 | WALLSTENT ESOPHAGEAL PROSTHESIS | Boston Scientific Scimed, Inc. | 1994-09-20 | 236 | 0 |
| K942154 | SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINA | Boston Scientific Scimed, Inc. | 1994-08-18 | 125 | 0 |
| K935292 | SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER | Boston Scientific Scimed, Inc. | 1994-06-10 | 220 | 0 |
| K934116 | WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION | Boston Scientific Scimed, Inc. | 1994-06-02 | 281 | 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