FDA 510(k)

ViewFlex Xtra ICE 球囊导管

K号: K223077 · 2022-12-07

申请人Irvine Biomedical, A St. Jude Medical Company

决定日期2022-12-07

产品代码OBJ

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

ViewFlex Xtra ICE Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. It received FDA 510(k) clearance on 2022-12-07 under 510(k) number K223077. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ViewFlex Xtra ICE Catheter?

ViewFlex Xtra ICE Catheter is a medical device that received FDA 510(k) clearance on 2022-12-07. The listed applicant is Irvine Biomedical, A St. Jude Medical Company. The 510(k) number is K223077.

When did ViewFlex Xtra ICE Catheter receive FDA 510(k) clearance?

ViewFlex Xtra ICE Catheter received FDA 510(k) clearance on 2022-12-07, under 510(k) number K223077.

Who is the listed applicant for ViewFlex Xtra ICE Catheter?

The FDA 510(k) record lists Irvine Biomedical, A St. Jude Medical Company as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewFlex Xtra ICE Catheter?

The FDA product code for ViewFlex Xtra ICE Catheter is OBJ.

相关器械（代码：OBJ）

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器械摘要

常见问题

相关临床试验

相关器械（代码：OBJ）

官方来源