FDA.reportPublic FDA data

510(k) K241239

Device
OrganProtex HTK Solution
Applicant
Bridge TO Life, Ltd.
510(k) number
K241239
Product code
KDL
Decision
Substantially Equivalent (SESE)
Decision date
2025-01-24
Date received
2024-05-03
Regulation
876.5880
Classification name
Set, Perfusion, Kidney, Disposable
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Mark Harper
Address
707 Skokie Blvd., Suite 340 Northbrook IL US 60062 60062

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KDL#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K221386PERF-GEN Pulsatile Perfusion SolutionInstitut Georges Lopez2022-06-14
K221387BEL-GEN Cold Storage SolutionInstitut Georges Lopez2022-06-14
K211842Servator M SALF SolutionS.A.L.F. Spa2021-12-20
K192408Custodiol HTK SolutionDr. Franz Kohler Chemie GmbH2020-04-24
K170150Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bagsS.A.L.F. Spa2017-10-20
K121736PERF-GEN PULSATILE PERFUSION SOLUTIONWaters Medical Systems, LLC2013-08-16
K121618BEL-GEN COLD STORAGE SOLUTIONWaters Medical Systems, LLC2013-06-14
K091656SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2LOrgan Recovery Systems, Inc.2010-03-11
K043461CUSTODIOLDr. Franz Kohler Chemie GmbH2005-02-28
K020924CUSTODIOL HTK SOLUTIONDr. Franz Kohler Chemie GmbH2003-01-06
K955497GAMBRO FH 22H FIBER HEMOFLTR/PRISMA FH 22H BLOOD TUBING/HEMOFLTR SETCobe Renal Care, Inc.1997-09-25
K944866VIASPAN (BELZER UW - CSS)The Dupont Merck Pharmaceutical Co.1996-04-22
K900492LABELING CHANGE - VIASPAN(TM) (BELZER UW)The DU Pont Co.1990-03-20
K891239MOP CATHETERBivona Medical Technologies1989-11-28
K883782BELZER UW-CSSDu Pont Critical Care1989-04-20