Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable

K-Number: K232852 · 2023-10-12

ApplicantCross Vascular, Inc.
Decision Date2023-10-12
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is a medical device manufactured by Cross Vascular, Inc.. It received FDA 510(k) clearance on 2023-10-12 under approval number K232852. 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 Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is a medical device that received FDA 510(k) clearance on 2023-10-12. It is manufactured by Cross Vascular, Inc.. The 510(k) number is K232852.

When was Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable approved by the FDA?

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable received FDA 510(k) clearance on 2023-10-12, under approval number K232852.

What company makes Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is manufactured by Cross Vascular, Inc..

What is the FDA product code for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

The FDA product code for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable is DXF.

Related Clinical Trials

NCT07548151 Guided Needle Insertion for Vascular Access COMPLETED NCT06358391 To Compare and Evaluate the Efficacy and Safety Between TS-RF System and BRK Transseptal Needles Used for Transseptal Puncture for Left Atrial Access. RECRUITING NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING NCT03445754 Effect of Transcutaneous Vagal Stimulation (TVS) on Endothelial Function in PAD COMPLETED

Other Devices by Cross Vascular, Inc.

K232809Cross Vascular RF Generator and Footswitch (optional accessory)

Related Devices (Code: DXF)

K182399Park Blade Septostomy CatheterCook Incorporated K211910Z-6 Atrioseptostomy CatheterNuMED, Inc. K221528Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy CatheterEdwards Lifesciences, LLC K243193Cross Wise™ Multi-Use RF Adapter CableCirca Scientific, Inc. K242076VersaCross™ RF WireBaylis Medical Company K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)Circa Scientific, Inc.

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.

↑