FDA 510(k)

Sprinter Legend 快速交換氣球擴張導管

K 號：K251970 · 2026-01-17

決定日期2026-01-17

產品代碼LOX

諮詢委員會履歷

決定相當於

器材摘要

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Ireland. It received FDA 510(k) clearance on 2026-01-17 under 510(k) number K251970. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2026-01-17. The listed applicant is Medtronic, Ireland. The 510(k) number is K251970.

When did Sprinter Legend Rapid Exchange Balloon Dilatation Catheter receive FDA 510(k) clearance?

Sprinter Legend Rapid Exchange Balloon Dilatation Catheter received FDA 510(k) clearance on 2026-01-17, under 510(k) number K251970.

Who is the listed applicant for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

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

What is the FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter?

The FDA product code for Sprinter Legend Rapid Exchange Balloon Dilatation Catheter is LOX.

其他以 Medtronic, Ireland 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。

K261428NC Euphora 快速交換氣球擴張導管 K261759Euphora Rapid Exchange (RX) 機械擴張導管 K252390望遠鏡導管延伸針管 K250787Liberant 靈活血栓切除系統

相關器械（代碼：LOX）

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。

K261428NC Euphora 快速交換氣球擴張導管Medtronic Ireland K261759Euphora Rapid Exchange (RX) 機械擴張導管Medtronic Ireland K252116消防員™ Pro PTCA 機械導管Shanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ 頸動脈-近端動脈成形術系統Verge Medical, Inc.K252295龍煉Terumo Corporation K242969潘特拉Pro；潘特拉LEOBiotronik, Inc.

官方來源

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