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FDA 510(k)

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)

K-Number: K252316 · 2025-08-19

ApplicantVenclose, Inc.
Decision Date2025-08-19
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is a medical device manufactured by Venclose, Inc.. It received FDA 510(k) clearance on 2025-08-19 under approval number K252316. 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 (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is a medical device that received FDA 510(k) clearance on 2025-08-19. It is manufactured by Venclose, Inc.. The 510(k) number is K252316.

When was Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) approved by the FDA?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) received FDA 510(k) clearance on 2025-08-19, under approval number K252316.

What company makes Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is manufactured by Venclose, Inc..

What is the FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)?

The FDA product code for Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100) is GEI.

Related Clinical Trials

NCT07429214 A Study of VARIPULSE Catheter and TRUPULSE Generator With VARIPULSE Pro Software in Participants With PAF or PsAF RECRUITING NCT06297291 Global Paradise System US Post Approval Study RECRUITING NCT06106594 VOLT CE Mark Study ACTIVE_NOT_RECRUITING NCT06223789 VOLT-AF IDE Clinical Study COMPLETED NCT06765356 Pragmatic Evaluation of a Pentaspline Pulsed Field Ablation System to Treat Atrial Fibrillation and Related Arrhythmias ACTIVE_NOT_RECRUITING NCT05971693 A Study For Treatment of Paroxysmal Atrial Fibrillation (PAF) With the OMNYPULSE Catheter and the TRUPULSE Generator COMPLETED

Other Devices by Venclose, Inc.

K160754Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter) K211806Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter 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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