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FDA PMA

覆蓋式支架血管接頭,血液透析通路電路

PMA 核准號:P240004 · 2025-07-18

申請人Phraxis, Inc.
決定日期2025-07-18
PMA 編號P240004
產品代碼SEQ
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Covered stent vascular connector, hemodialysis access circuit is the device name listed in this FDA 510(k) record. The listed applicant is Phraxis, Inc.. It received FDA 510(k) clearance on 2025-07-18. The device is classified under product code SEQ. It was reviewed by the CV advisory panel.

常見問題

What is the Covered stent vascular connector, hemodialysis access circuit?

Covered stent vascular connector, hemodialysis access circuit is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Phraxis, Inc..

When did Covered stent vascular connector, hemodialysis access circuit receive FDA 510(k) clearance?

The clearance date for Covered stent vascular connector, hemodialysis access circuit can be found in the official FDA records.

Who is the listed applicant for Covered stent vascular connector, hemodialysis access circuit?

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

What is the FDA product code for Covered stent vascular connector, hemodialysis access circuit?

The FDA product code for Covered stent vascular connector, hemodialysis access circuit is SEQ.

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