Cleared Special

Cross Wise? Multi-Use RF Adapter Cable

K243193 · Circa Scientific, Inc. · Cardiovascular
Nov 2024
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K243193 is an FDA 510(k) clearance for the Cross Wise? Multi-Use RF Adapter Cable, a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on November 26, 2024, 57 days after receiving the submission on September 30, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K243193 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2024
Decision Date November 26, 2024
Days to Decision 57 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DXF — Catheter, Septostomy
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5175

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