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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophageal sheath with distal balloon anchor
Definition Used to provide an endoluminal pathway to facilitate insertion of an endoscope or other specifically validated device into the upper gastrointestinal tract. A distal balloon anchor assists in keeping the sheath in place to facilitate positioning of the endoscope or other specifically validated device.
Product CodeQGG
Regulation Number 876.1510
Device Class 2


Premarket Reviews
ManufacturerDecision
BARONOVA, INC.
  SUBSTANTIALLY EQUIVALENT - KIT 1

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