FDA 510(k)

Cross Wise™ 多功能RF轉接線

K 號：K243193 · 2024-11-26

決定日期2024-11-26

產品代碼DXF

諮詢委員會履歷

決定相當於

器材摘要

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.

常見問題

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.

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。

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.K251007CrossWise RF 腺中隔進入系統（型號：CW-1085S、CW-1085A、CW-1012W、CW-1012C、CW-1085C、CW-1085V、CW-1013F）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。