Cleared Traditional

R2P Navicross

K231044 · Terumo Medical Corporation · Cardiovascular
Jul 2023
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K231044 is an FDA 510(k) clearance for the R2P Navicross, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Terumo Medical Corporation (Elkton, US). The FDA issued a Cleared decision on July 27, 2023, 106 days after receiving the submission on April 12, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K231044 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 2023
Decision Date July 27, 2023
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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