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FDA 510(k)

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter

K-Number: K211806 · 2021-08-03

ApplicantVenclose, Inc.
Decision Date2021-08-03
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is a medical device manufactured by Venclose, Inc.. It received FDA 510(k) clearance on 2021-08-03 under approval number K211806. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is a medical device that received FDA 510(k) clearance on 2021-08-03. It is manufactured by Venclose, Inc.. The 510(k) number is K211806.

When was Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter approved by the FDA?

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter received FDA 510(k) clearance on 2021-08-03, under approval number K211806.

What company makes Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is manufactured by Venclose, Inc..

What is the FDA product code for Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter?

The FDA product code for Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter is GEI.

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Other Devices by Venclose, Inc.

K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) K252316Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) K250068Venclose digiRF Generator (VCRFG1)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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