15 results
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21ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Venclose Radiofrequency System (digiRF Generator, EVSRF Catheter)
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).
FDA Enforcement
Class II
·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025
Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).
FDA Recall
Open, Classified
·Bard Peripheral Vascular Inc
1625 W 3rd St Bldg 1
850 W. Rio Salado Prkwy.
Tempe AZ 85281-2438·Product code GEI·August 21, 2025
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017842·K-Wire, Double Ended, Trocar Point, Diameter Si...
MSI Precision Specialty Instruments
FDA UDI
Med Saver, Inc.·00194613017859·K-Wire, Double Ended, Trocar Point, Diameter 0....
GRAFT DELIVERY SYSTEM MODEL SA-6115
FDA 510(k)
FDA Class 2
·General Hospital
ELECSYS TSH CALSET W/MODELS 04738551
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GORE DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·October 19, 2020
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·July 8, 2024
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W.L. GORE & ASSOCIATES·Product code DYB·October 6, 2016
ATLAS PLUS DR
FDA Adverse Event
Injury
·ST. JUDE MEDICAL INC., CRMD·Product code LWS·January 13, 2014
TOTAL ASR ACET IMP SIZE 52
FDA Adverse Event
Injury
·DEPUY INTL., LTD. - 8010379·Product code KWA·June 10, 2013
M SERIES
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·July 1, 2011
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·April 19, 2021
GORE® DRYSEAL FLEX INTRODUCER SHEATH
FDA Adverse Event
Injury
·W. L. GORE & ASSOCIATES, INC.·Product code DYB·May 30, 2023