FDA 510(k)

Optima 結構系統（Optima 包裝結構系統）

K 號：K252700 · 2025-09-26

決定日期2025-09-26

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 (Optima Packing 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 2025-09-26 under 510(k) number K252700. 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 Packing Coil System)?

Optima Coil System (Optima Packing Coil System) is a medical device that received FDA 510(k) clearance on 2025-09-26. The listed applicant is Balt USA, LLC. The 510(k) number is K252700.

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

Optima Coil System (Optima Packing Coil System) received FDA 510(k) clearance on 2025-09-26, under 510(k) number K252700.

Who is the listed applicant for Optima Coil System (Optima Packing 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 (Optima Packing Coil System)?

The FDA product code for Optima Coil System (Optima Packing 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 K243948Raptor 吸引針管；Balt 吸引管路組 K251383Prestige 環繞系統（Prestige 装箱線擴充）

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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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