FDA.reportPublic FDA data

510(k) K020925

Device
CARBODISSECTING ENDOSCOPE
Applicant
Endo Surgical Devices, Inc.
510(k) number
K020925
Product code
DWX
Decision
Substantially Equivalent (SESE)
Decision date
2003-04-29
Date received
2002-03-21
Regulation
870.4875
Classification name
Stripper, Artery, Intraluminal
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
DEBBIE IAMPIETRO
Address
7 Tiffany Trl. Hopkonton MA US 01748 01748

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K121415MOLLRING MULTITASCLeMaitre Vascular, Inc.2012-09-05
K032105ENDOHELIX ENDARTERECTOMY DEVICEEndarx, Inc.2003-10-30
K003719VASCULAR ARCHITECTS PERISCOPE DEVICEVascular Architects, Inc.2001-02-28
K950813MOLLRING CUTTERCardio Vascular Concepts, Inc.1995-07-25
K933498EXTERNAL VEIN STRIPPERApplied Medical Resources1994-03-23
K913803INTRALUMINAL ARTERY STRIPPEROmni-Tract Surgical, Div. Minn. Scientific, Inc.1992-04-24
K911099MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINEPilling Co.1991-06-25
K904944TRANSLUMINAL ENDARTERECTOMY DEVICEBaxter Healthcare Corp1990-12-17
K895878OLYMPUS VALVULOTOME W/DETACHABLE TIPOlympus Corp.1990-01-02
K894496OLYMPUS VALVULOTOME W/FIXED TIPOlympus Corp.1989-10-12
K890515PERIPHERAL ATHERECTOMY SYSTEMIntensive Technology, Inc.1989-05-23
K841521SCANLAN ENDARSECTORScanlan Intl., Inc.1984-08-03
K801063HALL ARTERIAL OSCILLATORAmerican Sterilizer Co.1980-09-26