K-numberK180169
Device nameEagleRay Long Sheath, 0.088 ID, 80cm, 90cm, 100cm and 110cm Lengths, EagleRay Access Catheter, 0.071 ID, 137cm Length, EagleRay Access Catheter, 0.055 ID, 137cm Length, EagleRay Access Catheter, 0.045 ID, 144cm Length, EagleRay Access Catheter, 0.035 ID, 158cm Length
ApplicantImperative Care, Inc.
Product codeDQY
Device classClass II
Decision dateAug 8, 2018
DecisionSubstantially Equivalent
Regulation870.1250
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