Product code DWX— Cardiovascular

FDA has cleared 14 devices under product code DWX between 1980 and 2012, filed by 13 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

• 20121 clearance
• 20032 clearances
• 20011 clearance
• 19951 clearance
• 19941 clearance
• 19921 clearance
• 19911 clearance
• 19902 clearances
• 19892 clearances
• 19841 clearance
• 19801 clearance

• Olympus Corp.2 clearances
• Vascular Architects, Inc.1 clearance
• Scanlan Intl., Inc.1 clearance
• Pilling Co.1 clearance
• Omni-Tract Surgical, Div. Minn. Scientific, Inc.1 clearance
• LeMaitre Vascular, Inc.1 clearance
• Intensive Technology, Inc.1 clearance
• Endo Surgical Devices, Inc.1 clearance
• Endarx, Inc.1 clearance
• Cardio Vascular Concepts, Inc.1 clearance

• K121415 — MOLLRING MULTITASCLeMaitre Vascular, Inc.·2012-09-05
• K032105 — ENDOHELIX ENDARTERECTOMY DEVICEEndarx, Inc.·2003-10-30
• K020925 — CARBODISSECTING ENDOSCOPEEndo Surgical Devices, Inc.·2003-04-29
• K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICEVascular Architects, Inc.·2001-02-28
• K950813 — MOLLRING CUTTERCardio Vascular Concepts, Inc.·1995-07-25
• K933498 — EXTERNAL VEIN STRIPPERApplied Medical Resources·1994-03-23
• K913803 — INTRALUMINAL ARTERY STRIPPEROmni-Tract Surgical, Div. Minn. Scientific, Inc.·1992-04-24
• K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINEPilling Co.·1991-06-25
• K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICEBaxter Healthcare Corp·1990-12-17
• K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIPOlympus Corp.·1990-01-02
• K894496 — OLYMPUS VALVULOTOME W/FIXED TIPOlympus Corp.·1989-10-12
• K890515 — PERIPHERAL ATHERECTOMY SYSTEMIntensive Technology, Inc.·1989-05-23
• K841521 — SCANLAN ENDARSECTORScanlan Intl., Inc.·1984-08-03
• K801063 — HALL ARTERIAL OSCILLATORAmerican Sterilizer Co.·1980-09-26