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 Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K234073
Device Name ICE Aspiration System
Applicant
Expanse Medical, Inc.
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Applicant Contact Shiva Ardakani
Correspondent
Expanse Medical, Inc.
7060 Koll Center Pkwy.
Suite #300
Pleasonton,  CA  94566
Correspondent Contact Shiva Ardakani
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received12/22/2023
Decision Date 04/19/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-