FDA 510(k)

XO Score LP 经皮腔内血管成形术评分导管，XO Score LP 导管

K号: K221986 · 2022-10-18

决定日期2022-10-18

产品代码PNO

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

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Transit Scientific, LLC. It received FDA 510(k) clearance on 2022-10-18 under 510(k) number K221986. The device is classified under product code PNO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is a medical device that received FDA 510(k) clearance on 2022-10-18. The listed applicant is Transit Scientific, LLC. The 510(k) number is K221986.

When did XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter receive FDA 510(k) clearance?

XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter received FDA 510(k) clearance on 2022-10-18, under 510(k) number K221986.

Who is the listed applicant for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

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

What is the FDA product code for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter?

The FDA product code for XO Score LP Percutaneous Transluminal Angioplasty Scoring Catheter, XO Score LP Catheter is PNO.

列明Transit Scientific, LLC为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K232258XO Constrain™ 经皮腔内血管成形术限制导管 K231821XO导管微导管（E20-090-S，E20-110-S，E20-130-S，E20-150-S，E20-175-S，E20-220-S，E20-090-B，E20-110-B，E20-130-B，E20-150-B，E20-175-B，E20-220-B，E26-090-S，E26-110-S，E26-130-S，E26-150-S，E26-175-S，E26-220-S，E26-090-B，E26-110-B，E26-130-B，E26-150-B，E26-175-B，E26-220-B）K214107XO 交叉冠状动脉支撑导管 K210322XO 交叉支撑导管

官方来源

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