用于良性前列腺增生的药物涂层前列腺扩张导管
PMA编号：P220029 · 2025-12-15
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决定日期2025-12-15
PMA 编号P220029
产品代码QXB
设备分类第3类
医疗专科U
咨询委员会GU
请注意，由于您只提供了“GU”这个词，我无法提供完整的翻译。如果您能提供完整的句子或段落，我将能够为您提供准确的翻译。
器械摘要
Drug coated prostatic dilation catheter for benign prostatic hyperplasia is the device name listed in this FDA 510(k) record. The listed applicant is Urotronic, Inc.. It received FDA 510(k) clearance on 2025-12-15. The device is classified under product code QXB. It was reviewed by the GU advisory panel.
常见问题
What is the Drug coated prostatic dilation catheter for benign prostatic hyperplasia?
Drug coated prostatic dilation catheter for benign prostatic hyperplasia is a medical device that received FDA 510(k) clearance on 2025-12-15. The listed applicant is Urotronic, Inc..
When did Drug coated prostatic dilation catheter for benign prostatic hyperplasia receive FDA 510(k) clearance?
The clearance date for Drug coated prostatic dilation catheter for benign prostatic hyperplasia can be found in the official FDA records.
Who is the listed applicant for Drug coated prostatic dilation catheter for benign prostatic hyperplasia?
The FDA 510(k) record lists Urotronic, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Drug coated prostatic dilation catheter for benign prostatic hyperplasia?
The FDA product code for Drug coated prostatic dilation catheter for benign prostatic hyperplasia is QXB.
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官方来源
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