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FDA 510(k)

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

K-Number: K241414 · 2024-09-26

ApplicantCirca Scientific, Inc.
Decision Date2024-09-26
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is a medical device manufactured by Circa Scientific, Inc.. It received FDA 510(k) clearance on 2024-09-26 under approval number K241414. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is a medical device that received FDA 510(k) clearance on 2024-09-26. It is manufactured by Circa Scientific, Inc.. The 510(k) number is K241414.

When was CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) approved by the FDA?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) received FDA 510(k) clearance on 2024-09-26, under approval number K241414.

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

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is manufactured by Circa Scientific, Inc..

What is the FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)?

The FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002) is DXF.

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Related PubMed Literature

PMID: 42082885 Precision Dosing of Vancomycin: A Systematic Review of Population Pharmacokinetics Models and Comparative Evaluation of Software Tools. Clinical pharmacokinetics (2026) PMID: 41915420 Analysis Model for Infant Incubator Adverse Events Using Retrieval-Augmented Generation Combined With Dual-Adapter Fine-Tuning: Development and Evaluation Study. JMIR medical informatics (2026) PMID: 41831468 Cardiometabolic prediction models for young people with psychosis spectrum disorders in the UK (PsyMetRiC 2.0): a retrospective, multicohort clinical prediction model study. The lancet. Psychiatry (2026) PMID: 41390636 Research on the current situation of animal models of abdominal wall hernia in the field of animal experiments: a systematic review of 9098 animals with abdominal wall hernia model. BMC surgery (2025)

Other Devices by Circa Scientific, Inc.

K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System K243193Cross Wise™ Multi-Use RF Adapter Cable K240004CardioCurve 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 K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) K243954PeriCross™ Epicardial Access Kit

Related Devices (Code: DXF)

K182399Park Blade Septostomy CatheterCook Incorporated K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterEdwards Lifesciences, LLC K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. K242076VersaCross™ RF WireBaylis Medical Company

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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