Cleared Traditional

RAIN Sheath? Tibial Pedal Introducer

K230704 · Cordis US Corp · Cardiovascular
Apr 2023
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K230704 is an FDA 510(k) clearance for the RAIN Sheath? Tibial Pedal Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cordis US Corp (Miami Lakes, US). The FDA issued a Cleared decision on April 24, 2023, 41 days after receiving the submission on March 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K230704 FDA.gov
FDA Decision Cleared SESE
Date Received March 14, 2023
Decision Date April 24, 2023
Days to Decision 41 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340