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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K180169
Device Name EagleRay 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
Applicant
Imperative Care, Inc.
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Applicant Contact Jake Wolenberg
Correspondent
Imperative Care, Inc.
1221 Innsbruck Dr.
Sunnyvale,  CA  94089
Correspondent Contact Jake Wolenberg
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/22/2018
Decision Date 08/08/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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