FDA 510(k)

CoAptix S システム

K番号: K252699 · 2026-04-10

申請者University of Utah, Department of Orthopaedics

決定日2026-04-10

製品コードHWC

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OR [翻訳] OR 注：原文が具体的な内容を含んでいないため、翻訳は単なる「OR」のままです。

決定大幅同等

医療機器の概要

CoAptix S System is the device name listed in this FDA 510(k) record. The listed applicant is University of Utah, Department of Orthopaedics. It received FDA 510(k) clearance on 2026-04-10 under 510(k) number K252699. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the CoAptix S System?

CoAptix S System is a medical device that received FDA 510(k) clearance on 2026-04-10. The listed applicant is University of Utah, Department of Orthopaedics. The 510(k) number is K252699.

When did CoAptix S System receive FDA 510(k) clearance?

CoAptix S System received FDA 510(k) clearance on 2026-04-10, under 510(k) number K252699.

Who is the listed applicant for CoAptix S System?

The FDA 510(k) record lists University of Utah, Department of Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoAptix S System?

The FDA product code for CoAptix S System is HWC. This falls under the Cardiovascular category.

申請者としてUniversity of Utah, Department of Orthopaedicsを記載するその他の記録

K230867ボーンボルトシステム

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