Cleared Traditional

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)

K241414 · Circa Scientific, Inc. · Cardiovascular
Sep 2024
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K241414 is an FDA 510(k) clearance for the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002), a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on September 26, 2024, 132 days after receiving the submission on May 17, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K241414 FDA.gov
FDA Decision Cleared SESE
Date Received May 17, 2024
Decision Date September 26, 2024
Days to Decision 132 days
Submission Type Traditional
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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