EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250)— 510(k) K243618

Name: FDA 510(k) clearance K243618
Creator: U.S. Food and Drug Administration
Published: 2025-06-17

Substantially Equivalent

Bridge TO Life

FDA 510(k) clearance K243618 for EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250), Substantially Equivalent on 2025-06-17. Applicant: Bridge TO Life. Device class: 2.

Clearance details

Applicant: Bridge TO Life
Product code: Code KDN
Device class: Class 2
Regulation: 21 CFR 876.5880
Advisory panel: Gastroenterology, Urology
Date received: 2024-11-22
Decision date: 2025-06-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KDN

view all

K261644 — Perfadex Plus2026-07-23
K260456 — VI°Port Liver Preservation System2026-06-01
K254305 — BAROguard Donor Lung Preservation System2026-01-30
K243870 — X°Port Lung Preservation System; X°Port Lung Preservation Solution2025-05-01
K243998 — DCX Disposable Cassette (DCX)2025-04-25

More clearances from Bridge TO Life

view all

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