FDA 510(k)

優麗環系統

K 號：K223386 · 2022-12-06

決定日期2022-12-06

產品代碼HCG

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

Optima Coil System is the device name listed in this FDA 510(k) record. The listed applicant is Balt USA, LLC. It received FDA 510(k) clearance on 2022-12-06 under 510(k) number K223386. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Optima Coil System?

Optima Coil System is a medical device that received FDA 510(k) clearance on 2022-12-06. The listed applicant is Balt USA, LLC. The 510(k) number is K223386.

When did Optima Coil System receive FDA 510(k) clearance?

Optima Coil System received FDA 510(k) clearance on 2022-12-06, under 510(k) number K223386.

Who is the listed applicant for Optima Coil System?

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

What is the FDA product code for Optima Coil System?

The FDA product code for Optima Coil System is HCG.

其他以 Balt USA, LLC 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。

K260199SLIM 微导管 K254223下一代 088 管子 K254221Optima 結構系統（OptiOne 結構系統）K252569載體XL輸送導管 K252700Optima 結構系統（Optima 包裝結構系統）K243948Raptor 吸引針管；Balt 吸引管路組

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相關器械（代碼：HCG）

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。

官方來源

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