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 Reprocessed Intravascular Ultrasound Catheter
510(k) Number K153090
Device Name Reprocessed Diagnostic Ultrasound Catheter
Applicant
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Applicant Contact RAFAL CHUDZIK
Correspondent
Innovative Health, LLC
1435 N. Hayden Rd.
Suite 100
Scottsdale,  AZ  85257
Correspondent Contact RAFAL CHUDZIK
Regulation Number870.1200
Classification Product Code
OWQ  
Date Received10/26/2015
Decision Date 03/10/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-