FDA 510(k)

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter

Número K: K200700 · 2020-05-14

Data da decisão2020-05-14

Código do produtoLIT

Comité consultivoCV

DecisãoSubstantially Equivalent

Resumo do dispositivo

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Creagh Medical, Ltd.. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K200700. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is Creagh Medical, Ltd.. The 510(k) number is K200700.

When did Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter receive FDA 510(k) clearance?

Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter received FDA 510(k) clearance on 2020-05-14, under 510(k) number K200700.

Who is the listed applicant for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

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

What is the FDA product code for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter?

The FDA product code for Surmodics Sublime Radial Access 014 RX PTA (Percutaneous Transluminal Angioplasty) Dilatation Catheter is LIT.

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Fonte oficial

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