FDA 510(k)

pRESET LITE 血栓切除术设备

K号: K231539 · 2023-10-21

决定日期2023-10-21

产品代码POL

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决定实质等同

器械摘要

pRESET LITE Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Phenox Limited. It received FDA 510(k) clearance on 2023-10-21 under 510(k) number K231539. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the pRESET LITE Thrombectomy Device?

pRESET LITE Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-10-21. The listed applicant is Phenox Limited. The 510(k) number is K231539.

When did pRESET LITE Thrombectomy Device receive FDA 510(k) clearance?

pRESET LITE Thrombectomy Device received FDA 510(k) clearance on 2023-10-21, under 510(k) number K231539.

Who is the listed applicant for pRESET LITE Thrombectomy Device?

The FDA 510(k) record lists Phenox Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for pRESET LITE Thrombectomy Device?

The FDA product code for pRESET LITE Thrombectomy Device is POL.

列明Phenox Limited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。

K242676pRESET Delta 溶栓设备与pRESET Delta LITE 溶栓设备 K222848预设血栓切除术设备 K191687pORTAL 可调向亲水导丝和 pORTAL EXT 扩展导丝

官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。