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 introducer, catheter
510(k) Number K152498
Device Name SoloPath Re-Collapsible Access System
Applicant
ONSET MEDICAL CORPORATION
13900 ALTON PARKWAY, SUITE 120
irvine,  CA  92618
Applicant Contact monika mcdole-russell
Correspondent
TERUMO Corporation
265 Davidson Ave, Suite 320
somerset,  NJ  08873
Correspondent Contact monika mcdole-russell
Regulation Number870.1340
Classification Product Code
DYB  
Date Received09/01/2015
Decision Date 01/05/2016
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-