FDA 510(k)

CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）

K 號：K251007 · 2025-05-01

決定日期2025-05-01

產品代碼DXF

諮詢委員會履歷

決定相當於

器材摘要

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) 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 2025-05-01 under 510(k) number K251007. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Circa Scientific, Inc.. The 510(k) number is K251007.

When did CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) receive FDA 510(k) clearance?

CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) received FDA 510(k) clearance on 2025-05-01, under 510(k) number K251007.

Who is the listed applicant for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)?

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 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)?

The FDA product code for CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F) is DXF.

其他以 Circa Scientific, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K243954PeriCross™ 心外膜進入套件 K243193Cross Wise™ 多功能RF轉接線 K241414CrossWise RF 腦室進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C）；CrossWise RF 适配器電纜（型號 CW-1002）K240004CardioCurve 可導導管小彎曲，40cm (CC-1040S)；CardioCurve 可導導管中彎曲，40cm (CC-1040M)；CardioCurve 可導導管大彎曲，40cm (CC-1040L)；CardioCurve 可導導管小彎曲，61cm (CC-1061S)；CardioCurve 可導導管中彎曲，61cm (CC-1061M)；CardioCurve 可導導管大彎曲，61cm (CC-1061L)；CardioCurve 可導導管小彎曲，71cm (CC-1071S)；CardioCurve 可導導管中彎曲，71cm (CC-1071M)；CardioCurve Steer K222311CIRCA MATRIX12 M 食管溫度探針及溫度監測系統

相關器械（代碼：DXF）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K261745雷電導管穿隔穿刺系統 (TPS)ElectroWire Medical K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC K260292HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical K252419HOTWIRE RF 線導管（901XXX）；HOTWIRE RF 線導管（902XXX）Atraverse Medical, Inc.K243193Cross Wise™ 多功能RF轉接線Circa Scientific, Inc.K242076VersaCross™ 電波針Baylis Medical Company

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。