Devices

Beacon Tip Royal Flush Plus HighFlow Catheter

  • Modèle / numéro de série
    All Lots. Catalog prefixes HNR5.0  Catalog/product number; Global/order number HNR5.0-35-100-P-10S-0 G09697 HNR5.0-35-100-P-10S-CFP G11264 HNR5.0-35-100-P-10S-PIG G09059 HNR5.0-35-100-P-8S-VCF G31403 HNR5.0-35-100-P-NS-0 G10313 HNR5.0-35-100-ST-10S-0 G09565 HNR5.0-35-100-ST-10S-PIG G09525 HNR5.0-35-110-P-10S-0 G11241 HNR5.0-35-110-P-10S-PIG G11265 HNR5.0-35-65-P-8S-VCF G12129 HNR5.0-35-70-P-10S-0 G09411 HNR5.0-35-70-P-10S-CFP G11262 HNR5.0-35-70-P-10S-PIG G08832 HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280 HNR5.0-35-70-P-4S-PED G11281 HNR5.0-35-70-P-NS-0 G11959 HNR5.0-35-70-ST-10S-0 G09564 HNR5.0-35-70-ST-10S-PIG G09050 HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282 HNR5.0-35-90-P-6S-PED G11729 HNR5.0-35-90-P-8S-VCF G12799 HNR5.0-35-90-ST-10S-0 G11641 HNR5.0-35-90-ST-10S-PIG G09197 HNR5.0-38-100-P-10S-0 G11267 HNR5.0-38-100-P-10S-CFP G11268 HNR5.0-38-100-P-10S-PIG G09285 HNR5.0-38-100-P-NS-0 G27874 HNR5.0-38-110-P-10S-0 G09461 HNR5.0-38-110-P-10S-PIG G11269 HNR5.0-38-70-P-10S-0 G11270 HNR5.0-38-70-P-10S-CFP G11271 HNR5.0-38-70-P-10S-PIG G11272 HNR5.0-38-70-P-NS-0 G11289 HNR5.0-38-80-P-10S-OPC G27877 HNR5.0-38-90-P-10S-0 G11273 HNR5.0-38-90-P-10S-CFP G11274 HNR5.0-38-90-P-10S-PIG G11275
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
  • Description du dispositif
    Beacon¿ Tip Royal Flush¿ Plus High-Flow Catheter || Catheter, Intravascular, Diagnostic || The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
  • Manufacturer
    Cook Inc.
  • 1 Event

Fabricant

Cook Inc.
  • Adresse du fabricant
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Société-mère du fabricant (2017)
    Cook Group Incorporated
  • Source
    USFDA

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Device Recall Beacon Tip Royal Flush Plus HighFlow Catheter
  • Modèle / numéro de série
    All lots of the following Product numbers: HNR4.0-35-100-P-10S-0,  HNR4.0-35-100-P-10S-CFP,  HNR4.0-35-100-P-10S-PIG,  HNR4.0-35-100-P-6S-VCF,  HNR4.0-35-100-P-NS-0, HNR4.0-35-100-P-NS-DAV,  HNR4.0-35-100-P-NS-SIM1,  HNR4.0-35-100-P-NS-SIM2,  HNR4.0-35-100-ST-10S-0, HNR4.0-35-100-ST-10S-PIG,  HNR4.0-35-100-ST-6S-PED,  HNR4.0-35-110-P-10S-PIG,  HNR4.0-35-120-P-6S-PED, HNR4.0-35-120-ST-6S-PED,  HNR4.0-35-125-P-10S-0,  HNR4.0-35-125-P-10S-PIG,  HNR4.0-35-50-P-NS-0,  HNR4.0-35-65-P-8S-VCF, HNR4.0-35-70-P-10S-0,  HNR4.0-35-70-P-10S-CFP,  HNR4.0-35-70-P-10S-PIG,  HNR4.0-35-70-P-4S-PED,  HNR4.0-35-70-P-6S-PED, HNR4.0-35-70-P-NS-0,  HNR4.0-35-70-ST-10S-0,  HNR4.0-35-70-ST-10S-PIG,  HNR4.0-35-70-ST-6S-PED,  HNR4.0-35-90-P-10S-0, HNR4.0-35-90-P-10S-CFP,  HNR4.0-35-90-P-10S-PIG,  HNR4.0-35-90-P-6S-PED,  HNR4.0-35-90-P-8S-VCF,  HNR4.0-35-90-P-NS-0, HNR4.0-35-90-ST-10S-0,  HNR4.0-35-90-ST-10S-PIG
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Description du dispositif
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. || For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
    Cook Inc.