# Venclose Inc

> Medical device manufacturer record on deviCERTS, compiled from public registries. Venclose Inc is a medical device manufacturer based in the United States, with 26 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class I and IIb) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/venclose-inc>
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED
- EUDAMED SRN: US-MF-000001372
- DUNS: 085838983

## Figures

- Devices: 26
- EU certificates: 1
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 22, EUDAMED 9, FDA 510(k) 4
- Device classes: FDA Class II 17, EU Class I 6, EU Class IIb 3
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 7 devices
- EMDN [C01 Arterio-venous system devices](https://devicerts.com/categories/emdn/C01): 2 devices

## Sites and related companies

- Authorised representative: [ICON (LR) Limited](https://devicerts.com/representatives/icon-lr-limited-ie-ar-000006507) (Ireland)

## Devices

The first 26 of 26, in the order of the canonical page, which lists them all.

- [Venclose System Power Cord VCPCN](https://devicerts.com/devices/venclose-system-power-cord-vcpcn) · Class II · GUDID · status: Active · open recall
- [Venclose™ EVSRF™ Catheter VC-10A2.5-6F-60 \[10X\]](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60-10x) · Class II · GUDID · status: Active · open recall
- [Venclose System Power Cord VCPCC](https://devicerts.com/devices/venclose-system-power-cord-vcpcc) · Class II · GUDID · status: Active · open recall
- [Venclose System Power Cord VCPCH](https://devicerts.com/devices/venclose-system-power-cord-vcpch) · Class II · GUDID · status: Active · open recall
- [Venclose Maven Catheter VC056F](https://devicerts.com/devices/venclose-maven-catheter-vc056f) · Class II · GUDID · status: Active · open recall
- [Venclose™ EVSRF™ Catheter VC-10A2.5-6F-100 \[10X\]](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100-10x) · Class II · GUDID · status: Active · open recall
- [Venclose™ EVSRF™ Catheter VC-10A2.5-6F-60 \[5X\]](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60-5x) · Class II · GUDID · status: Active · open recall
- [Venclose System Power Cord VCPCB](https://devicerts.com/devices/venclose-system-power-cord-vcpcb) · Class II · GUDID · status: Active · open recall
- [Venclose™ EVSRF™ Catheter VC-10A2.5-6F-100 \[5X\]](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100-5x) · Class II · GUDID · status: Active · open recall
- [EVSRF Procedure Pack VC-PP-EVSRF](https://devicerts.com/devices/evsrf-procedure-pack-vc-pp-evsrf) · Class II · GUDID · status: Listed
- [Venclose System Power Cord VCPCA](https://devicerts.com/devices/venclose-system-power-cord-vcpca) · Class II · GUDID · status: Active · open recall
- [Venclose System Foot Pedal VCFP1](https://devicerts.com/devices/venclose-system-foot-pedal-vcfp1) · Class II · GUDID · status: Active · open recall
- [Venclose System Power Cord VCPCM](https://devicerts.com/devices/venclose-system-power-cord-vcpcm) · Class II · GUDID · status: Active · open recall
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-i) · ref VC-PC-I · Class I · EUDAMED, GUDID · status: Active
- [Venclose digiRF Generator (VCRFG1)](https://devicerts.com/devices/venclose-digirf-generator-vcrfg1-gei) · ref K250068 · Class II · 510(k) · status: Active · decision 2025-02-04 · open recall
- [Venclose digiRF Generator with Maven Catheter, Venclose Maven System, Venclose digiRF Generator, Venclose Maven Catheter](https://devicerts.com/devices/venclose-digirf-generator-with-maven-catheter-venclose-maven-gei) · ref K211806 · Class II · 510(k) · status: Active · decision 2021-08-03 · open recall
- [Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)](https://devicerts.com/devices/venclose-radiofrequency-system-digirf-generator-evsrf-cathet-gei) · ref K160754 · Class II · 510(k) · status: Active · decision 2016-09-09 · open recall
- [Venclose digiRF Generator (VCRFG1); Venclose EVSRF Catheter (VC10A256F60, VC10A256F100)](https://devicerts.com/devices/venclose-digirf-generator-vcrfg1-venclose-evsrf-catheter-vc1-gei) · ref K252316 · Class II · 510(k) · status: Active · decision 2025-08-19
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-l) · ref VC-PC-L · Class I · EUDAMED, GUDID · status: Active
- [Venclose EVSRF Catheter](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-60) · ref VC-10A2.5-6F-60 · Class IIb · EUDAMED, GUDID · status: Active
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-k) · ref VC-PC-K · Class I · EUDAMED, GUDID · status: Active
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-j) · ref VC-PC-J · Class I · EUDAMED, GUDID · status: Active
- [Venclose EVSRF Catheter](https://devicerts.com/devices/venclose-evsrf-catheter-vc-10a2-5-6f-100) · ref VC-10A2.5-6F-100 · Class IIb · EUDAMED, GUDID · status: Active
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-g) · ref VC-PC-G · Class I · EUDAMED, GUDID · status: Active
- [Venclose Power Cord](https://devicerts.com/devices/venclose-power-cord-vc-pc-e) · ref VC-PC-E · Class I · EUDAMED, GUDID · status: Active
- [Venclose digiRF Generator](https://devicerts.com/devices/venclose-digirf-generator-vc-rfg-1) · ref VC-RFG-1 · Class IIb · EUDAMED, GUDID · status: Active

## EU certificates

- 10000475258-PA-NoMA-USA · Quality management system · MDR · notified body DNV Product Assurance AS · issued 2023-08-29 · expires 2028-08-29 · status: issued

## Source and citation

- Cite as: Venclose Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/venclose-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/venclose-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/venclose-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.