Cleared Special

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)

K251007 · Circa Scientific, Inc. · Cardiovascular
May 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K251007 is an FDA 510(k) clearance for the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F), a Catheter, Septostomy (Class II — Special Controls, product code DXF), submitted by Circa Scientific, Inc. (Englewood, US). The FDA issued a Cleared decision on May 1, 2025, 30 days after receiving the submission on April 1, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K251007 FDA.gov
FDA Decision Cleared SESE
Date Received April 01, 2025
Decision Date May 01, 2025
Days to Decision 30 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

Similar Devices — DXF Catheter, Septostomy

All 19
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
K253799 · Pressure Products Medical Device Manufacturing, LLC · Mar 2026
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
K260292 · Atraverse Medical · Feb 2026
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
K252419 · Atraverse Medical, Inc. · Aug 2025
Cross Wise? Multi-Use RF Adapter Cable
K243193 · Circa Scientific, Inc. · Nov 2024
VersaCross? RF Wire
K242076 · Baylis Medical Company · Nov 2024
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. · Sep 2024

More from Circa Scientific, Inc.

View all
PeriCross? Epicardial Access Kit
K243954 · DYB · Apr 2025
Cross Wise? Multi-Use RF Adapter Cable
K243193 · DXF · Nov 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
K241414 · DXF · Sep 2024
CardioCurve Steerable Sheath Small Curl, 40cm (CC-1040S ); CardioCurve Steerable Sheath Medium Curl, 40cm (CC-1040M ); CardioCurve Steerable Sheath Large Curl, 40cm (CC-1040L ); CardioCurve Steerable Sheath Small Curl, 61cm (CC-1061S); CardioCurve Steerable Sheath Medium Curl, 61cm (CC-1061M ); CardioCurve Steerable Sheath Large Curl, 61cm (CC-1061L); CardioCurve Steerable Sheath Small Curl, 71cm (CC-1071S ); CardioCurve Steerable Sheath Medium Curl, 71cm (CC-1071M ); CardioCurve Steer
K240004 · DYB · Jan 2024
CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System
K222311 · FLL · May 2023