Cleared Traditional

XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)

K231821 · Transit Scientific, LLC · Cardiovascular

Nov 2023

Decision

161d

Days

Class 2

Risk

About This 510(k) Submission

K231821 is an FDA 510(k) clearance for the XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,), a Catheter, Continuous Flush (Class II — Special Controls, product code KRA), submitted by Transit Scientific, LLC (Salt Lake City, US). The FDA issued a Cleared decision on November 29, 2023, 161 days after receiving the submission on June 21, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1210.

Submission Details

510(k) Number	K231821 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 21, 2023
Decision Date	November 29, 2023
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF