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, Percutaneous
510(k) Number K220331
Device Name 091 Balloon Guide Catheter
Applicant
Inneuroco, Inc.
19700 Stirling Rd., Suite 1
Pembroke Pines,  FL  33332
Applicant Contact Marc Litzenberg
Correspondent
Inneuroco, Inc.
19700 Stirling Rd., Suite 1
Pembroke Pines,  FL  33332
Correspondent Contact Garry Koroshec
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received02/04/2022
Decision Date 07/29/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-