FDA 510(k)

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)

Número K: K251185 · 2025-10-22

Data da decisão2025-10-22

Código do produtoQEW

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is the device name listed in this FDA 510(k) record. The listed applicant is Intervene. It received FDA 510(k) clearance on 2025-10-22 under 510(k) number K251185. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is a medical device that received FDA 510(k) clearance on 2025-10-22. The listed applicant is Intervene. The 510(k) number is K251185.

When did Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) receive FDA 510(k) clearance?

Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) received FDA 510(k) clearance on 2025-10-22, under 510(k) number K251185.

Who is the listed applicant for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

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

What is the FDA product code for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)?

The FDA product code for Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) is QEW.

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