Home / Device Classification / DWP

DWP — Dilator, Vessel, Surgical Class II

FDA Device Classification

Classification Details

Product Code
DWP
Device Class
Class II
Regulation Number
870.4475
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K220981fehling surgical instrumentsSUPERPLAST Double-Occluder, SUPERPLAST Vascular ProbeApril 20, 2023
K183438geomed medizin-technik gmbh andGeomed Vascular DilatorsSeptember 3, 2019
K163524fetzer medical gmbh and co. kgVessel DilatorJune 29, 2017
K130896synovis life technologiesVASCULAR PROBE, VASCULAR PROBE ESApril 24, 2013
K100518instrumed internationalINSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054August 31, 2010
K030788geister medizin technikKAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSJuly 12, 2003
K960312r d intlRDI CARDIAC INSULATION PADApril 19, 1996
K912548vascutechLEMAITRE-BOOKWALTER VESSEL DEVICESSeptember 18, 1991
K911475united states endoscopy groupLAPAROSCOPIC VESSEL ARTICULATORJuly 2, 1991
K910682bio-vascularROBICSEK PROBE/RETRACTORMay 8, 1991
K905159bio-vascularFLO-RESTER(R) VESSEL SIZERFebruary 7, 1991
K902143baxter healthcareFOGARTY VESSEL CALIBRATOROctober 16, 1990
K891786pioneering technologiesPTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)October 12, 1989
K833676cimed intlSURGICAL VESSEL DILATORS-CATHERIZA-March 19, 1984
K832595abbott laboratoriesVESSEL DILATORAugust 31, 1983
K822687american edwards laboratoriesREUSABLE FOGARTY FLEXIBLE CALIBRATOROctober 4, 1982
K812935american edwards laboratoriesFOGARTY FLEXIBLE PROBENovember 16, 1981
K810894american edwards laboratoriesFOGARTY FLEXIBLE CALIBRATORMay 15, 1981
K792134shileyBONCHEK-SHILEY VEIN DISTENTION SYSTEMDecember 4, 1979
K790938shileySAPHENOUS VEIN IRRIGATION, PRESSURIZATIOJune 13, 1979