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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K200037
FOIA Releasable 510(k) K200037
Device Name Piccolo Medical SmartPICC System
Applicant
Piccolo Medical, Inc.
101 Mississippi, St.
San Francisco,  CA  94107
Applicant Contact Alexey Salamini
Correspondent
Arina Consulting
27 Hilltop Dr.
San Carlos,  CA  94070
Correspondent Contact Allison Kumar
Regulation Number880.5970
Classification Product Code
LJS  
Date Received01/08/2020
Decision Date 01/22/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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