Boston Scientific Scimed, Inc.

Medical device manufacturer in Maple Grove, MN.

35510(k) clearances
5PMA approvals
0recalls

Device types

510(k) clearances

510(k)DeviceDecision
K041727Modification to Atlantis PV Imaging Catheter, Model 36456OBJ · Special 07/23/2004SE
K030617PT2 Guide Wire and Addwire Extension WireDQX · Abbreviated 05/21/2003SE
K024048Modification to Boston Scientific Express Biliary LD Premounted Stent SystemFGE · Special 01/06/2003SESU
K021735Boston Scientific Ultra-Soft SV Balloon Dilatation CatheterDQY · Traditional 08/08/2002SE
K021901Wallgraft Tracheobronchial Endoprothesis with Unistep Plus Delivery SystemJCT · Special 07/09/2002SE
K012822Modificiation to: Biliary Wallstent Endoprostheis with Monorail Delivery System, Model…FGE · Special 10/24/2001SESU
K012216Niroyal Biliary Premounted Stent SystemFGE · Special 08/17/2001SESU
K000743Boston Scientific Scimed Atlantis Coronary Imaging Catheter, Model C4020DQO · Traditional 09/06/2000SE
K000001Wallgraft Tracheobronchial Endoprosthesis and Unistep Delivery SystemJCT · Traditional 06/05/2000SE
K000956Modification to Scimed 6F Impulse Angiographic CathatersDQO · Special 04/21/2000SE
K993232Wallstent Biliary Endoprosthesis and Unistep Plus Delivery SystemFGE · Traditional 12/30/1999SESU
K992123Scimed Impulse Angiographic CathetersDQO · Traditional 08/23/1999SE
K982005Wallstent Transhepatic Biliary EndoprosthesisFGE · Traditional 09/02/1998SE
K982077Selector Diagnostic CatheterDQO · Traditional 08/11/1998SE
K980453Schneider Guider Softip Guiding CathetersDQY · Traditional 08/11/1998SE
K982184Wallstent EndoprosthesisJCT · Special 07/21/1998SE
K981413Schneider Guider Softip Guiding CathetersDQY · Special 05/13/1998SE
K980113Wallstent Enteral EndoprosthesisMUM · Traditional 04/03/1998SE
K980163Wallstent Tracheobronchial Endoprosthesis and Wallstent Tracheobronchial Endoprosthesis…JCT · Traditional 03/13/1998SE
K972512Smash Percutaneous Transluminal Angioplasty (Pta) Cardiovascular Devices PanelLIT · Traditional 02/12/1998SE
K964119Wallstent Transhepatic Biliary EndoprosthesisFGE · Traditional 04/28/1997SE
K964121Wallstent Tracheobronchial EndoprosthesisJCT · Traditional 12/04/1996ST
K961999Schneider Guider Softip Guiding CathetersDYG · Traditional 11/19/1996SE
K961499Laguna Softip Diagnostic CathetersDQO · Traditional 10/17/1996SE
K961507Walstent Tracheobronchial EndoprosthesisJCT · Traditional 07/10/1996ST
K961296Wallstent Tracheobronchial EndoprosthesisJCT · Traditional 07/10/1996ST
K954290Wallstent Enteral EndoprothesisMQR · Traditional 07/10/1996SE
K961262Wallstent Transhepatic Biliary Endoprosthesis/Wallstent Endoscopic Biliary EndoprosthesisFGE · Traditional 05/10/1996SE
K945494Wallstent(R) Tracheobronchial EndoprosthesisJCT · Traditional 03/03/1995ST
K943622Schneider Pink Power Softip Guidnig CatheterDQY · Traditional 11/30/1994SE
K940396Wallstent Esophageal Prosthesis (Double)ESW · Traditional 10/03/1994SE
K940395Wallstent Esophageal ProsthesisESW · Traditional 09/20/1994SE
K942154Schneider Total Cross and Match 35 Percutanewous Transluminal Angioplasty CathetersLIT · Traditional 08/18/1994SE
K935292Schneider Guidezilla Softip Guiding CatheterDQY · Traditional 06/10/1994SE
K934116Wallstent Tracheobronchial Prosthesis ModificationJCT · Traditional 06/02/1994ST

PMA approvals