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510(k) K220981

Device
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Applicant
Fehling Surgical Instruments, Inc.
510(k) number
K220981
Product code
DWP
Decision
Substantially Equivalent (SESE)
Decision date
2023-04-20
Date received
2022-04-04
Regulation
870.4475
Classification name
Dilator, Vessel, Surgical
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Hayden Hosch
Address
1690 Stone Village Ln. Suite 721 Kennesaw GA US 30152 30152

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DWP#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K183438Geomed Vascular DilatorsGeomed Medizin-Technik GmbH & Co.2019-09-03
K163524Vessel DilatorFetzer Medical GmbH & Co. KG2017-06-29
K130896VASCULAR PROBE, VASCULAR PROBE ESSynovis Life Technologies, Inc.2013-04-24
K100518INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054Instrumed International, Inc.2010-08-31
K030788KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORSGeister Medizin Technik GmbH2003-07-12
K960312RDI CARDIAC INSULATION PADR D Intl.1996-04-19
K912548LEMAITRE-BOOKWALTER VESSEL DEVICESVascutech, Inc.1991-09-18
K911475LAPAROSCOPIC VESSEL ARTICULATORUnited States Endoscopy Group, Inc.1991-07-02
K910682ROBICSEK PROBE/RETRACTORBio-Vascular, Inc.1991-05-08
K905159FLO-RESTER(R) VESSEL SIZERBio-Vascular, Inc.1991-02-07
K902143FOGARTY VESSEL CALIBRATORBaxter Healthcare Corp1990-10-16
K891786PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)Pioneering Technologies, Inc.1989-10-12
K833676SURGICAL VESSEL DILATORS-CATHERIZA-Cimed Intl., Inc.1984-03-19
K832595VESSEL DILATORAbbott Laboratories1983-08-31
K822687REUSABLE FOGARTY FLEXIBLE CALIBRATORAmerican Edwards Laboratories1982-10-04