Company ยท US
Boston Scientific Scimed
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2004. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
44recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GBR | 25 | |
| JCT | Prosthesis, Tracheal, Expandable | 10 |
| DQY | Catheter, Percutaneous | 8 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 8 |
| DQO | Catheter, Intravascular, Diagnostic | 6 |
| MAF | Stent, Coronary | 5 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | 3 |
| DTK | Filter, Intravascular, Cardiovascular | 2 |
| ESW | Prosthesis, Esophageal | 2 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 2 |
| 74G | 1 | |
| DQX | Wire, Guide, Catheter | 1 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 1 |
| DYG | Catheter, Flow Directed | 1 |
| MQR | Stent, Colonic, Metallic, Expandable | 1 |
| MUM | Stent, Metallic, Expandable, Duodenal | 1 |
| NIQ | Coronary Drug-Eluting Stent | 1 |
| OBJ | Catheter, Ultrasound, Intravascular | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 23, 2004 | K041727 | MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 Boston Scientific Scimed, Inc. | OBJ |
| May 21, 2003 | K030617 | PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE Boston Scientific Scimed, Inc. | DQX |
| Jan 6, 2003 | K024048 | MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM Boston Scientific Scimed, Inc. | FGE |
| Aug 8, 2002 | K021735 | BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER Boston Scientific Scimed, Inc. | DQY |
| Jul 9, 2002 | K021901 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Scimed, Inc. | JCT |
| Oct 24, 2001 | K012822 | MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX Boston Scientific Scimed, Inc. | FGE |
| Aug 17, 2001 | K012216 | NIROYAL BILIARY PREMOUNTED STENT SYSTEM Boston Scientific Scimed, Inc. | FGE |
| Sep 6, 2000 | K000743 | BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 Boston Scientific Scimed, Inc. | DQO |
| Jun 5, 2000 | K000001 | WALLGRAFT TRACHEOBRONCHIAL ENDOPROSTHESIS AND UNISTEP DELIVERY SYSTEM Boston Scientific Scimed, Inc. | JCT |
| Apr 21, 2000 | K000956 | MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS Boston Scientific Scimed, Inc. | DQO |
| Dec 30, 1999 | K993232 | WALLSTENT BILIARY ENDOPROSTHESIS AND UNISTEP PLUS DELIVERY SYSTEM Boston Scientific Scimed, Inc. | FGE |
| Aug 23, 1999 | K992123 | SCIMED IMPULSE ANGIOGRAPHIC CATHETERS Boston Scientific Scimed, Inc. | DQO |
| Sep 2, 1998 | K982005 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. | FGE |
| Aug 11, 1998 | K982077 | SELECTOR DIAGNOSTIC CATHETER Boston Scientific Scimed, Inc. | DQO |
| Aug 11, 1998 | K980453 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. | DQY |
| Jul 21, 1998 | K982184 | WALLSTENT ENDOPROSTHESIS Boston Scientific Scimed, Inc. | JCT |
| May 13, 1998 | K981413 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. | DQY |
| Apr 3, 1998 | K980113 | WALLSTENT ENTERAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | MUM |
| Mar 13, 1998 | K980163 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS AND WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS WITH PERMALUME COVERING Boston Scientific Scimed, Inc. | JCT |
| Feb 12, 1998 | K972512 | SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL Boston Scientific Scimed, Inc. | LIT |
| Apr 28, 1997 | K964119 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. | FGE |
| Dec 4, 1996 | K964121 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | JCT |
| Nov 19, 1996 | K961999 | SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS Boston Scientific Scimed, Inc. | DYG |
| Oct 17, 1996 | K961499 | LAGUNA SOFTIP DIAGNOSTIC CATHETERS Boston Scientific Scimed, Inc. | DQO |
| Jul 10, 1996 | K961507 | WALSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | JCT |
| Jul 10, 1996 | K961296 | WALLSTENT TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | JCT |
| Jul 10, 1996 | K954290 | WALLSTENT ENTERAL ENDOPROTHESIS Boston Scientific Scimed, Inc. | MQR |
| May 10, 1996 | K961262 | WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS/WALLSTENT ENDOSCOPIC BILIARY ENDOPROSTHESIS Boston Scientific Scimed, Inc. | FGE |
| Mar 3, 1995 | K945494 | WALLSTENT(R) TRACHEOBRONCHIAL ENDOPROSTHESIS Boston Scientific Scimed, Inc. | JCT |
| Nov 30, 1994 | K943622 | SCHNEIDER PINK POWER SOFTIP GUIDNIG CATHETER Boston Scientific Scimed, Inc. | DQY |
| Oct 3, 1994 | K940396 | WALLSTENT ESOPHAGEAL PROSTHESIS (DOUBLE) Boston Scientific Scimed, Inc. | ESW |
| Sep 20, 1994 | K940395 | WALLSTENT ESOPHAGEAL PROSTHESIS Boston Scientific Scimed, Inc. | ESW |
| Aug 18, 1994 | K942154 | SCHNEIDER TOTAL CROSS AND MATCH 35 PERCUTANEWOUS TRANSLUMINAL ANGIOPLASTY CATHETERS Boston Scientific Scimed, Inc. | LIT |
| Jun 10, 1994 | K935292 | SCHNEIDER GUIDEZILLA SOFTIP GUIDING CATHETER Boston Scientific Scimed, Inc. | DQY |
| Jun 2, 1994 | K934116 | WALLSTENT TRACHEOBRONCHIAL PROSTHESIS MODIFICATION Boston Scientific Scimed, Inc. | JCT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2006 | Boston Scientific Scimed Boston Scientific Sentinol Self-Expanding Nitinol Biliary Stent System with Over-the-Wire Delivery System. Catalog No. 38948-8607. Sterile. Made in USA 5905 Nathan Lane, Plymouth, MN 55442, USA. Terminated |
FGE | K032025 |
| Jan 24, 2006 | Boston Scientific Scimed Mach 1 6F JR 3.5 Guide Catheter. Catalog No. 34356-685. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacture: Boston Scientific Scimed, Inc., One Sc Terminated |
DQY | K010874 |
| Jan 24, 2006 | Boston Scientific Scimed Mach 1 6F Kimny Guide Catheter. Catalog No. 34356-583. Sterilized with ethylene oxide gas. Nonpyrogenic. Intended for one procedure use only. Manufacturer: Boston Scientific Scimed, Inc., One Sci Terminated |
DQY | K010874 |
| Dec 23, 2005 | Boston Scientific Scimed Titanium Greenfield Vena Cava Filter with 12 Fr./4,0 mm Introducer System. Catalog no. M001503010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Technology Terminated |
DTK | K901659 |
| Dec 23, 2005 | Boston Scientific Scimed Stainless Steel Greenfield Vena Cava Filter with 12 Fr. / 4,0 mm FlexCarrier Capsule. Catalog no. M001505010. Sterile EO. Single Use Only. Manufacturer: Boston Scientific Cork Ltd., Business and Terminated |
DTK | K964284 |
| Jun 25, 2005 | Boston Scientific Scimed PTFE (Polytetrafluoroethylene) felt. Catalog #s: M002000193041, M002000193061, M002000193811,
M002000193821, M002000193931, M002000193841, M002000193861, M002000193881. Terminated |
DXZ | None listed |
| Jan 28, 2005 | Boston Scientific Scimed RunWay 6F Cardiovascular Guide Catheter. Terminated |
DQY | K033441 |
| Aug 13, 2004 | Boston Scientific Scimed WALLSTENT Endoprostheses with UNISTEP Plus Delivery System. Terminated |
JCT | K992510 |
| Jul 20, 2004 | Boston Scientific Scimed TAXUS Express Paclitaxel-Eluting MONORAIL Coronary Stent System (3.5 x 32mm).
On August 5, 2004 an additional 38 lots were added to this recall, the following TAXUS Express2 Paclitaxel-Eluting Corona Terminated |
NIQ | None listed |
| Jul 20, 2004 | Boston Scientific Scimed Impulse 5F 145 (degree) Multipack Angiographic Catheters, Catalog Number H749163913011 Terminated |
DQO | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 1 cm Tip and 20 mm Balloon, Catalog Number H74903628151 Terminated |
LOX | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071051 Terminated |
LOX | None listed |
| Oct 15, 2003 | Boston Scientific Scimed Ace Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter with 2cm Tip 20 mm Balloon, Catalog Number H74902071011 Terminated |
LOX | None listed |
| Aug 29, 2003 | Boston Scientific Scimed Boston Scientific Medi-Tech Imager II 5F Selective Angiographic Catheter Terminated |
74G | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Boston Scientific Scimed Monorail Express 2 Coronary Stent System, 3.5 mm x 32 mm, Catalog number 35050-3235 Terminated |
MAF | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-7020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-6020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-5020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-5015 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 38990-4020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/1.5 cm/90 cm, Reference Catalog Number 38990-4015
, Product Number H7493791540150 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-6020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/2.0 cm/150 cm, Reference Catalog Number 38950-5020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-7020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6515 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-6015 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-5520 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-5015 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4520 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4515 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 2.0 cm/150 cm, Reference Catalog Number 37916-4020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/ 1.5 cm/150 cm, Reference Catalog Number 37916-4015 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-7020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 7.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-7015 Terminated |
GBR | None listed |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.5 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-6520 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 6.0 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-6015 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 5.0 mm/ 2.0 cm/90 cm, Reference Catalog Number 37915-5020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.5 mm/ 1.5 cm/90 cm, Reference Catalog Number 37915-4515 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm/2.0 cm/90 cm, Reference Catalog Number 37915-4020 Terminated |
GBR | K021735 |
| Aug 12, 2003 | Boston Scientific Scimed Ultra-soft SV Monorail Balloon Dilatation Catheters, 4.0 mm / 1.5 cm /90 cm (balloon width/balloon length/catheter length), Reference Catalog Number 37915-4015 Terminated |
GBR | K021735 |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius 4.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500401 Terminated |
MAF | None listed |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius 3.0 mm x 31 mm Self-Expanding Coronary Stent with Over-the-Wire Delivery System, Catalog Number H74917500301 Terminated |
MAF | None listed |
| Apr 22, 2003 | Boston Scientific Scimed Boston Scientific Scimed Radius Monorail 4.0 mm x 31 mm Stent Systems, Catalog Number H74917485400 Terminated |
MAF | None listed |
| Apr 9, 2003 | Boston Scientific Scimed Boston Scientific Scimed Express 2 Monorail 2.5 mm 12mm Coronary Stent System, Catalog Number H7493505012250 Terminated |
MAF | None listed |