Devices

Device Recall NC Stormer Zipper MX Balloon Dilation Catheter

  • Modèle / numéro de série
    1) PMA # P790017/S79 2) Device Listing Number 2112641 3) Facility Registration number 2953200 4) lot codes 44DOE015, 44DOE016, 44DOE019, 44DOE022, 44DOE023, 44DOE020, 44DOE024, 44DOE025, 44DOE026, 44DOE021, 44DOE029, 44DOE032 5) Item numbers NCS2506ZP, NCS3016ZP, NCS2511ZP, NCS3516ZP, NCS3511ZP, NCS3521ZP, NCS3006ZP, NCS3011ZP, NCS2516ZP, NCS4006ZP, NCS4011ZP, NCS3021ZP
  • Classification du dispositif
    Cardiovascular Devices
  • Classe de dispositif
    2
  • Dispositif implanté ?
    No
  • Distribution
    Product was distributed to 40 hospitals
  • Description du dispositif
    Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
  • Manufacturer
    Medtronic Vascular
  • 1 Event

Fabricant

Medtronic Vascular
  • Adresse du fabricant
    Medtronic Vascular, 3576 Unocal Pl, Santa Rosa CA 95403-1774
  • Source
    USFDA