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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 the device name listed in this FDA 510(k) record. The listed applicant is Cross Vascular, Inc.. It received FDA 510(k) clearance on 2023-10-12 under 510(k) 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. The listed applicant is Cross Vascular, Inc.. The 510(k) number is K232852.

When did Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable receive FDA 510(k) clearance?

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

Who is the listed applicant for Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable?

The FDA 510(k) record lists Cross Vascular, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Cross Vascular, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K232809Cross Vascular RF Generator and Footswitch (optional accessory)

Related Devices (Code: DXF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire MedicalK253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLCK260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse MedicalK252419HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical, Inc.K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)Circa Scientific, Inc.K243193Cross Wise™ Multi-Use RF Adapter CableCirca 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.

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