EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618)
Description
EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) by Bridge TO Life, an FDA 510(k) cleared gastroenterology, urology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243618
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. EasiSlush® Sodium Chloride Solution for Sterile Slush Preparation (BTLE-1250) (K243618) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191006 | EasiSlush | Bridge TO Life, Ltd. | 2019 |
Trace the full predicate network for K243618
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.