Boston Scientific Scimed, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 35
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 | July 23, 2004 |
| K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE | May 21, 2003 |
| K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM | January 6, 2003 |
| K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER | August 8, 2002 |
| K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM | July 9, 2002 |
| K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX | October 24, 2001 |
| K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM | August 17, 2001 |
| K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 | September 6, 2000 |
| K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM | June 5, 2000 |
| K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS | April 21, 2000 |
| K993232 | WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM | December 30, 1999 |
| K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS | August 23, 1999 |
| K982005 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS | September 2, 1998 |
| K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | August 11, 1998 |
| K982077 | SELECTOR DIAGNOSTIC CATHETER | August 11, 1998 |
| K982184 | WALLSTENT ENDOPROSTHESIS | July 21, 1998 |
| K981413 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS | May 13, 1998 |
| K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS | April 3, 1998 |
| K980163 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALU | March 13, 1998 |
| K972512 | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL | February 12, 1998 |