FDA.report

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
N

Related Records

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

Related GUDID Devices

Primary DIBrandCompanyPublished
04058749118773NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119145NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119138NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119121NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119046NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119039NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119022NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119015NAFehling Instruments GmbH & Co. KG2024-04-09
04058749118858NAFehling Instruments GmbH & Co. KG2024-04-09
04058749118841NAFehling Instruments GmbH & Co. KG2024-04-09
04058749118834NAFehling Instruments GmbH & Co. KG2024-04-09
04058749118827NAFehling Instruments GmbH & Co. KG2024-04-09
04058749119244NAFehling Instruments GmbH & Co. KG2024-03-27
04058749118803NAFehling Instruments GmbH & Co. KG2024-03-27
04058749119190NAFehling Instruments GmbH & Co. KG2024-03-27
04058749119213NAFehling Instruments GmbH & Co. KG2024-03-27
04058749119237NAFehling Instruments GmbH & Co. KG2024-03-27
04058749118810NAFehling Instruments GmbH & Co. KG2023-12-08
04058749119183NAFehling Instruments GmbH & Co. KG2023-12-08
04058749119206NAFehling Instruments GmbH & Co. KG2023-12-08
04058749118957NAFehling Instruments GmbH & Co. KG2023-12-06
04058749119053NAFehling Instruments GmbH & Co. KG2023-12-06
04058749119114NAFehling Instruments GmbH & Co. KG2023-12-06
04058749119220NAFehling Instruments GmbH & Co. KG2023-12-06
04058749119091NAFehling Instruments GmbH & Co. KG2023-05-22
04058749119107NAFehling Instruments GmbH & Co. KG2023-05-22
04058749119084NAFehling Instruments GmbH & Co. KG2023-05-22
04058749119077NAFehling Instruments GmbH & Co. KG2023-05-22
04058749119060NAFehling Instruments GmbH & Co. KG2023-05-22
04058749119008NAFehling Instruments GmbH & Co. KG2023-05-22

Other 510(k) Records For Product Code DWP

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