Devices · Saranas Inc.

Saranas Early Bird Bleed Monitoring System

Saranas Inc. is listed for Saranas Early Bird Bleed Monitoring System (K230273). The FDA list gives May 25, 2023 as the date of the final decision. The lead panel is Cardiovascular, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QFJ as “Intravascular Bleed Monitor”: An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K230273

Official FDA database record

Date of final decision

May 25, 2023

Company on the FDA list

Saranas Inc.

Lead panel

Cardiovascular

Primary product code

QFJ

openFDA device name for the code

Intravascular Bleed Monitor

Device class

2

Regulation number

870.1345

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary