The EVSRF catheter is a sterile, single-use disposable medical device for endovenous radiofrequency ablation, a procedure in which a refluxing vein is thermally coagulated to permanently eliminate the vein from blood circulation. The catheter has a long shaft for insertion into a vein, a handle with start/stop button, and a connector cable. The catheter shaft has a heating element that is energized by the digiRF radiofrequency generator, which is a multi-voltage energy delivery system with touchscreen control that automatically sets the non-adjustable treatment parameters for the catheter. A button on the catheter (or a foot pedal attached to the generator) begins an automated treatment cycle of 20 seconds long at a set temperature of 120 ¿C, and the treatment stops automatically when complete. The catheter is used within a sterile operative field, while the generator remains outside the sterile operative field at all times.

Detalles del retiro

Fabricante

Bard Peripheral Vascular Inc

Distribuidor

Worldwide - U.S. Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, SC, SD, TN, TX, UT, VA, WA, WI and WV. The countries of Australia, Singapore, Austria, Belgium, Czechia, Denmark, France, Germany, Greece, Ireland, Italy, Poland, Slovenia Spain, Sweden, Switzerland, United Kingdom, United Arab Emirates, and South Africa.

Lote

Catalog Number: VC-10A2.5-6F-100 UDI does: (01)00858254006015(17)241009(10)65497423 (01)00858254006015(17)241006(10)66030181 (01)00858254006015(17)241011(10)66599182 (01)00858254006015(17)241017(10)66634308 (01)00858254006015(17)241020(10)66784768 (01)00858254006015(17)241026(10)66793709 (01)00858254006015(17)241028(10)66793710 (01)00858254006015(17)241103(10)66897727 (01)00858254006015(17)241113(10)66947733 (01)00858254006015(17)241117(10)67054619 (01)00858254006015(17)241130(10)67308611 (01)00858254006015(17)250322(10)69548248 (01)00858254006015(17)250419(10)69548249 (01)00858254006015(17)250423(10)69548250 (01)00858254006015(17)250427(10)69567357 (01)00858254006015(17)250511(10)69567358 (01)00858254006015(17)250515(10)70322501 (01)00858254006015(17)250607(10)70523716 (01)00858254006015(17)250523(10)70597994 (01)00858254006015(17)250525(10)70751594 (01)00858254006015(17)250606(10)70791660 (01)00858254006015(17)250613(10)71054985 (01)00858254006015(17)250620(10)71197454 (01)00858254006015(17)250703(10)71197455 (01)00858254006015(17)250801(10)71197574 (01)00858254006015(17)250622(10)71319092 (01)00858254006015(17)250630(10)71361455 (01)00858254006015(17)250712(10)71589682 (01)00858254006015(17)250721(10)71780480 (01)00858254006015(17)250724(10)71780481 (01)00858254006015(17)250821(10)71974718 (01)00858254006015(17)250803(10)72167973 (01)00858254006015(17)250821(10)72216631 (01)00858254006015(17)250809(10)72216758 (01)00858254006015(17)250810(10)72282293 (01)00858254006015(17)250828(10)72440542 (01)00858254006015(17)250914(10)72491306 (01)00858254006015(17)250905(10)72609982 (01)00858254006015(17)250912(10)72735944 (01)00858254006015(17)250920(10)72845915 (01)00858254006015(17)250927(10)73024457 (01)00858254006015(17)250929(10)73184835 (01)00858254006015(17)251005(10)73218082 (01)00858254006015(17)251011(10)73319890 (01)00858254006015(17)251012(10)73424182 (01)00858254006015(17)251102(10)73441733 (01)00858254006015(17)251121(10)73808592 (01)00858254006015(17)251125(10)74103378 (01)00858254006015(17)251127(10)74171115 (01)00858254006015(17)251129(10)74219123 (01)00858254006015(17)260112(10)74355356 (01)00858254006015(17)241108(10)V67114001 (01)00858254006015(17)241108(10)V67114002 (01)00858254006015(17)241108(10)V67114003 Lot Numbers: 65497423 66030181 66599182 66634308 66784768 66793709 66793710 66897727 66947733 67054619 67308611 69548248 69548249 69548250 69567357 69567358 70322501 70523716 70597994 70751594 70791660 71054985 71197454 71197455 71197574 71319092 71361455 71589682 71780480 71780481 71974718 72167973 72216631 72216758 72282293 72440542 72491306 72609982 72735944 72845915 73024457 73184835 73218082 73319890 73424182 73441733 73808592 74103378 74171115 74219123 74355356 V67114001 V67114002 V67114003 Catalog Number: VC-10A2.5-6F-60 UDI codes: (01)00858254006008(17)241013(10)66186400 (01)00858254006008(17)241024(10)66793696 (01)00858254006008(17)241102(10)66793697 (01)00858254006008(17)241107(10)66793698 (01)00858254006008(17)241021(10)66802218 (01)00858254006008(17)241031(10)66863470 (01)00858254006008(17)241110(10)66981017 (01)00858254006008(17)241120(10)67017611 (01)00858254006008(17)241125(10)67105253 (01)00858254006008(17)241115(10)67190839 (01)00858254006008(17)241123(10)67241133 (01)00858254006008(17)241128(10)67429950 (01)00858254006008(17)241204(10)67429951 (01)00858254006008(17)241204(10)67429952 (01)00858254006008(17)250410(10)69548196 (01)00858254006008(17)250327(10)69548197 (01)00858254006008(17)250416(10)69548198 (01)00858254006008(17)250331(10)69659895 (01)00858254006008(17)250502(10)69659896 (01)00858254006008(17)250505(10)69748757 (01)00858254006008(17)250509(10)69928277 (01)00858254006008(17)250601(10)70414634 (01)00858254006008(17)250517(10)70487066 (01)00858254006008(17)250519(10)70634659 (01)00858254006008(17)250529(10)70673130 (01)00858254006008(17)250604(10)70868426 (01)00858254006008(17)250608(10)70933358 (01)00858254006008(17)250612(10)70994254 (01)00858254006008(17)250614(10)71075353 (01)0

Clasificación de riesgo

Class II

Área (FDA)

device

País

United States