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 K152261
FOIA Releasable 510(k) K152261
Device Name PICC Tip Positioning Aid
Applicant
Nostix, LLC
5541 Central Ave., Suite 170
Boulder,  CO  80301
Applicant Contact Peter Nelson
Correspondent
Salus Ventures, LLC
5335 Holmes Place
Boulder,  CO  80303
Correspondent Contact Jim Lewis
Regulation Number880.5970
Classification Product Code
LJS  
Date Received08/11/2015
Decision Date 10/21/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-