510(k) clearances

Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)

Bridge TO Life · Gastroenterology, Urology

K243840Substantially EquivalentTraditionalKDN
Open FDA's page for this record
Third party flag
N
City
Northbrook
Advisory committee description
Gastroenterology, Urology
Address 1
707 Skokie Blvd., Suite 340
Statement or summary
Summary
Product code
KDN
Zip code
60062
Applicant
Bridge TO Life
Decision date
2025-03-26
Decision code
SESE
Country code
US
Device name
Belzer MPS® (UW Machine Perfusion Solution) (BMPS-001)
Advisory committee
GU
Contact
Mark Harper
K number
K243840
State
IL
Date received
2024-12-13
Review advisory committee
GU
Postal code
60062
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
System, Perfusion, Kidney
Medical specialty description
Gastroenterology, Urology
Regulation number
876.5880
Device class
2
Registration number
3007710603, 3017298490, 3004068499, 3021739803, 2183744, 3014498869, 3007685782, 3005694677, 3007583504, 9615922, 3010765841, 3020224798, 3011175555, 3010005578, 3000143502, 1720929, 3038515260, 1067143, 3011292417, 1319660, 3014967969, 3024820181, 2132588, 3010163695, 3027669473, 3008388260, 2123774, 1423929, 3031600052, 3017223202, 1420032, 3008998256, 3010680515, 1450662, 3031884833, 1721676, 3010034260
FEI number
3003750694, 3010877980, 3007710603, 3017298490, 3004068499, 3021739803, 2183744, 3001451660, 1000136478, 3014498869, 3007685782, 3005694677, 3007583504, 3010765841, 3011175555, 3010005578, 3000143502, 1720929, 3038515260, 3011292417, 3024820181, 3014967969, 3010163695, 3027669473, 3008388260, 1000221028, 3001640191, 2123774, 3031600052, 3017223202, 1420032, 3008998256, 3010680515, 1450662, 3031884833, 1721676, 3010034260
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.