Devices

STEERABLE CORONARY SINUS CATHETER

  • 모델명 / 제조번호(시리얼번호)
    Model Catalog: SCS01 (Lot serial: 669235); Model Catalog: SCS01 (Lot serial: 666556); Model Catalog: SCS01 (Lot serial: 678238); Model Catalog: SCS01 (Lot serial: 751043); Model Catalog: EP (Lot serial: >10 NUMBERS CONTACT MFG); Model Catalog: SCS01 (Lot serial: 763122); Model Catalog: SCS01 (Lot serial: 755821)
  • 제품 설명
    STEERABLE CORONARY SINUS CATHETER MODEL SCS01
  • Manufacturer
    EDWARDS LIFESCIENCES (CANADA) INC.
  • 1 Event

제조사

EDWARDS LIFESCIENCES (CANADA) INC.

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Device Recall Steerable Coronary Sinus Catheter
  • 모델명 / 제조번호(시리얼번호)
    Lot numbers: 678238B, 751043B, 755821B, 763122B.
  • 의료기기 분류등급
    Cardiovascular Devices
  • 의료기기 등급
    2
  • 이식된 장치?
    No
  • 유통
    Nationwide Distribution.
  • 제품 설명
    Steerable Coronary Sinus Catheter, Model SCS01, 9 Fr x 20.4", Sterile R, Edwards Lifesciences Port Access Systems. || Device is a three-lumen, 9 Fr catheter with an elastomeric balloon near its tip for occluding the coronary sinus in order to retrograde perfuse the coronary circulation. An 11 Fr catheter introducer sheath, which is compatible with the catheter contamination guard, is packaged with these catheters.
  • Manufacturer
    Edwards Lifesciences, LLC