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FDA 510(k)

Cross Wise™ Multi-Use RF Adapter Cable

K-Number: K243193 · 2024-11-26

ApplicantCirca Scientific, Inc.
Decision Date2024-11-26
Product CodeDXF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Cross Wise™ Multi-Use RF Adapter Cable is the device name listed in this FDA 510(k) record. The listed applicant is Circa Scientific, Inc.. It received FDA 510(k) clearance on 2024-11-26 under 510(k) number K243193. 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 Wise™ Multi-Use RF Adapter Cable?

Cross Wise™ Multi-Use RF Adapter Cable is a medical device that received FDA 510(k) clearance on 2024-11-26. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K243193.

When did Cross Wise™ Multi-Use RF Adapter Cable receive FDA 510(k) clearance?

Cross Wise™ Multi-Use RF Adapter Cable received FDA 510(k) clearance on 2024-11-26, under 510(k) number K243193.

Who is the listed applicant for Cross Wise™ Multi-Use RF Adapter Cable?

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

What is the FDA product code for Cross Wise™ Multi-Use RF Adapter Cable?

The FDA product code for Cross Wise™ Multi-Use RF Adapter Cable is DXF.

Other records listing Circa Scientific, 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.

K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)K243954PeriCross™ Epicardial Access KitK241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)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 SteerK222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring SystemK200943Circa S-Cath M Esophageal Temperature Probe and Temperature Monitoring System

View all 7 devices →

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.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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