FDA 510(k)

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter

K-번호: K191073 · 2019-10-22

결정일2019-10-22

제품 코드NUJ

자문 위원회SU

결정Substantially Equivalent

기기 요약

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Vein 360, LLC. It received FDA 510(k) clearance on 2019-10-22 under 510(k) number K191073. The device is classified under product code NUJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is a medical device that received FDA 510(k) clearance on 2019-10-22. The listed applicant is Vein 360, LLC. The 510(k) number is K191073.

When did Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter receive FDA 510(k) clearance?

Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter received FDA 510(k) clearance on 2019-10-22, under 510(k) number K191073.

Who is the listed applicant for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA 510(k) record lists Vein 360, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter?

The FDA product code for Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter is NUJ.

Vein 360, LLC를 신청인으로 등재한 기타 기록

K232584Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter K230928Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter K230584Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter

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