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510(k) K132314

Device
MEDLINE ANTI-REFLUX VALVE
Applicant
MEDLINE INDUSTRIES, INC.
510(k) number
K132314
Product code
FEG  
Decision
Substantially Equivalent (SESE)
Decision date
2013-09-18
Date received
2013-07-25
Regulation
876.5980
Classification name
Tube, Double Lumen For Intestinal Decompression And/or Intubation
Medical specialty
Gastroenterology/Urology
Review panel
Gastroenterology/Urology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
MATT CLAUSEN
Address
One Medline Pl. Mundelein IL US 60060 60060

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code FEG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K17161914Fr Colon Decompression Set, Macon Colon Decompression SetCook Ireland, Ltd.2017-08-01
K053410GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTORKendall2006-01-06
K040388NEXT GENERATION SALEM SUMPKendall2004-05-17
K971354KNOTT NG TUBEMichael M. Knott, M.D.1997-11-19
K960176DAVOL NASOGASTRIC SUMP TUBE W/PREVENT FILTERC.R. Bard, Inc.1996-07-24
K926073ULTRAVAC-NG(TM) NASOGASTRIC SUMP SUCTION TUBESurgimark, Inc.1995-05-15
K935781ARGYLE SALEM SUMP TUBE ANTI-REFLUX VALVE INSERTION TRAYSherwood Medical Co.1995-01-27
K921104LOPEZ VALVE WITH NG SUMP TUBEIcu Medical, Inc.1992-10-26
K900035WILSON-COOK COLON DECOMPRESSION SETWilson-Cook Medical, Inc.1990-03-07
K880850KEITH NASOGASTRIC SUMP TUBE W/ANTI-REFLUX VALVEKmb Medical Products Co.1988-05-26
K772282HODGE TUBEMallinckrodt Critical Care1978-03-09
K771048CATHETERS, DRAINAGEAxiom Medical, Inc.1977-07-19

Legacy Summary#

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FDA Review#

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