FDA 510(k)

Pantheris LV 鑫脂切除針管

K 號：K230005 · 2023-06-06

決定日期2023-06-06

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

Pantheris LV Atherectomy Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Avinger, Inc.. It received FDA 510(k) clearance on 2023-06-06 under 510(k) number K230005. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pantheris LV Atherectomy Catheter?

Pantheris LV Atherectomy Catheter is a medical device that received FDA 510(k) clearance on 2023-06-06. The listed applicant is Avinger, Inc.. The 510(k) number is K230005.

When did Pantheris LV Atherectomy Catheter receive FDA 510(k) clearance?

Pantheris LV Atherectomy Catheter received FDA 510(k) clearance on 2023-06-06, under 510(k) number K230005.

Who is the listed applicant for Pantheris LV Atherectomy Catheter?

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

What is the FDA product code for Pantheris LV Atherectomy Catheter?

The FDA product code for Pantheris LV Atherectomy Catheter is MCW.

其他以 Avinger, Inc. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K230594虎眼ST CTO-Crossing 尿管 K212468虎眼CTO-Crossing 穿刺導管 K212047貓鼬系統 K201330虎眼CTO-Crossing 穿刺導管 K182341貓鼬SV K173862貓鼬系統

查看所有 12 項裝置 →

相關器械（代碼：MCW）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K260244Auryon 開心術系統Eximo Medical K250723FreedomFlow™ 軌道環形動脈內脫落術系統 (H6005/ 4Fr 3-球體配置)Cardio Flow Inc.,K250385超級精英雷射動脈內切除針Spectranetics K242757Rotarex 銳術系統Bard Peripheral Vascular, Inc.K242947FreedomFlow™ 軌道環形動脈內切除系統Cardio Flow Inc.,K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層Eximo Medical, Ltd.

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。