FDA 510(k)

タイガートライバー21再血管化装置、タイガートライバー17再血管化装置、タイガートライバー13再血管化装置

K番号: K230429 · 2023-04-17

決定日2023-04-17

製品コードNRY

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定大幅同等

医療機器の概要

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Rapid Medical , Ltd.. It received FDA 510(k) clearance on 2023-04-17 under 510(k) number K230429. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is a medical device that received FDA 510(k) clearance on 2023-04-17. The listed applicant is Rapid Medical , Ltd.. The 510(k) number is K230429.

When did Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device receive FDA 510(k) clearance?

Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device received FDA 510(k) clearance on 2023-04-17, under 510(k) number K230429.

Who is the listed applicant for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

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

What is the FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device?

The FDA product code for Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device is NRY.