OrganProtex HTK Solution— 510(k) K241239

Substantially Equivalent

Bridge TO Life, Ltd.

FDA 510(k) clearance K241239 for OrganProtex HTK Solution, Substantially Equivalent on 2025-01-24. Applicant: Bridge TO Life, Ltd.. Device class: 2.

Clearance details

Applicant: Bridge TO Life, Ltd.
Product code: Code KDL
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-05-03
Decision date: 2025-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDL

K221386 — PERF-GEN Pulsatile Perfusion Solution2022-06-14
K221387 — BEL-GEN Cold Storage Solution2022-06-14
K211842 — Servator M SALF Solution2021-12-20
K192408 — Custodiol HTK Solution2020-04-24
K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml PVC free bags2017-10-20

More clearances from Bridge TO Life, Ltd.

DEN250009 — VitaSmart Hypothermic Oxygenated Perfusion System2026-01-15
K203262 — Cannula for Organ Perfusion2021-07-01
K191006 — EasiSlush2019-09-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.