Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
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 Fransico,  CA  94107
Applicant Contact Alexey Salamini
Correspondent
Arina Consulting
27 Hilltop Drive
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
-
-