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510(k) K102136

VESSEL GUARDIAN by Lexion Medical, LLC — Product Code HIF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2010
Date Received
July 29, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Insufflator, Laparoscopic
Device Class
Class II
Regulation Number
884.1730
Review Panel
OB
Submission Type

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  • K132203 — PNEUVIEW XE VERYCLEAR GAS EVACUATION CANNULA (September 20, 2013)
  • K132204 — INSUFLOW SYNERGY XL PORT (August 22, 2013)
  • K120640 — INSUFLOW SYNERGY PORT (July 18, 2012)
  • K112357 — VESSEL GUARDIAN (November 10, 2011)
  • K101320 — VASOVAPOR (June 24, 2010)
  • K091366 — INSUFLOW DEWHEART (September 3, 2009)
  • K090456 — INSUFLOW (August 26, 2009)

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  • K231342 — Insufflator (OPTO-IFL1000) (September 20, 2023)
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