510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250009Unknown

VitaSmart Hypothermic Oxygenated Perfusion System

Bridge to Life Ltd, Northbrook IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN250009 is the FDA 510(k) clearance record for VitaSmart Hypothermic Oxygenated Perfusion System, a class II device, cleared for Bridge TO Life, Ltd. on under FDA product code SGY (Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant). FDA's definition for product code SGY reads: "A hypothermic machine perfusion system and accessories for orthotopic liver transplant is a device that performs oxygenated perfusion of liver grafts at sub-physiological temperatures until it is transplanted into a recipient patient. This...". FDA records list 7 510(k) clearances for Bridge TO Life, Ltd., from to . As of , FDA records show no recalls naming DEN250009.

Clearance record

Decision date
Received
(290 days to decision)
Product code
SGY Hypothermic Machine Perfusion System And Accessories For Orthotopic Liver Transplant
Regulation
21 CFR 876.5881
Device class
Class II
Review panel
Gastroenterology, Urology
Applicant
Bridge TO Life, Ltd. 707 Skokie Blvd., Suite 340, Northbrook IL
Third party review
No

Clearances, product code SGY

Trailing 12 months
1 clearance under product code SGY in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SGY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260