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510(k) K150882

Edwards Suture Fastening System by Edwards Lifesciences, LLC — Product Code HCF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 16, 2015
Date Received
April 2, 2015
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Ligature Passing And Knot Tying
Device Class
Class I
Regulation Number
878.4800
Review Panel
SU
Submission Type

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Other clearances for product code HCF

  • K931379 — MICROVASIVE INSURG LAPTIE SUTURE LIGATOR (July 13, 1993)
  • K851452 — VALTRAC PURSESTING DEVICE (June 12, 1985)
  • K841617 — STROVER HOOK (August 27, 1984)
  • K790577 — HEMORRHOIDAL LIGATOR (April 23, 1979)