FDA 510(k)

Cross Wise™ Multi-Use RF Adapter Cable

Numéro K : K243193 · 2024-11-26

Date de décision2024-11-26

Code produitDXF

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

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.

Questions fréquentes

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.

Essais cliniques associés

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Autres dossiers indiquant Circa Scientific, Inc. en tant que demandeur

K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)K243954PeriCross™ Epicardial Access Kit K241414CrossWise 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 Steer K222311CIRCA MATRIX12 M Esophageal Temperature Probe and Temperature Monitoring System

Dispositifs connexes (Code : DXF)

K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)Atraverse Medical K252419HOTWIRE 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

Source officielle

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