FDA 510(k) Applications for Medical Device Product Code "DWP"
(Dilator, Vessel, Surgical)

FDA 510(k) Number Applicant Device Name Decision Date
K220981 Fehling Surgical Instruments, Inc. SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe 04/20/2023
K163524 Fetzer Medical GmbH & Co. KG Vessel Dilator 06/29/2017
K030788 GEISTER MEDIZINTECHNIK GMBH KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS 07/12/2003
K183438 Geomed Medizin-Technik GmbH & Co. Geomed Vascular Dilators 09/03/2019
K100518 INSTRUMED INTERNATIONAL, INC. INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054 08/31/2010
K960312 R D INTL. RDI CARDIAC INSULATION PAD 04/19/1996
K130896 SYNOVIS LIFE TECHNOLOGIES, INC. VASCULAR PROBE, VASCULAR PROBE ES 04/24/2013


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