StarClose SE Vascular Closure System

Manufacturer

  • Manufacturer Parent Company (2017)
  • Manufacturer comment
    “We are in constant communication with regulatory agencies and competent authorities worldwide which allows us to implement global recalls or in-country communication quickly and effectively,” Abbott, which now owns St. Jude Medical told ICIJ in a statement. In addition to sending global notices to physicians worldwide, we also make sure that product advisories are available online and classification of product recalls and product advisories are determined by global regulatory bodies which can impact the timing in any given country. MD companies follow varying regulations in different countries. In come countries software is not regulated so a recall in one country related to software would not be classified as a recall or field action in another. In addition, review cycles within the regulatory process can be different in each country which can impact communication and recall timing.
  • Source
    HSAHSA

16 devices with a similar name

Learn more about the data here

  • Model / Serial
    Model: , Affected: 50831K1, 50903K1, 50911K1,50921K1, 50924K1, 50929K1, 51002K1, 51008K1, 51016K1, 51026K1, 51029K1,51103K1
  • Manufacturer
  • Model / Serial
    Part No. 14679-01 50908K1 50916K1 51013K1 51021K1 51106K1 5101241 5101441 5101941 5102141 5102741 5103141 5110541 5111041 5121041 5121541 5121741 5122341 6012641 6012941 6020341 6020841 6021141 6021641 6021841 6022541 6022941 6030341 6030841 6041241  Part No. 14679-02 50831K1 50903K1 50911K1 50921K1 50924K1 50929K1 51002K1 51008K1 51016K1 51026K1 51029K1 51103K1 5111741 5112041 5112441 5112741 5120141 5120441 6010641 6011141 6011441 6011941 6012241 6031041 6031541 6032241 6032941 6041941 6042141 6042641 6042941 6051141 6051341 6051941 6052441 6061541 6100341
  • Product Classification
  • Device Class
    3
  • Implanted device?
    No
  • Distribution
    US: Germany, Italy, Puerto Rico, Spain, Sweden, Switzerland,
  • Product Description
    StarClose SE Vascular Closure System, Part No. 14679-01, 14679-02. || The UDI is 08717648079467. || The GMDN is 47411.
  • Manufacturer
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