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 K193607
Device Name BOBBY Balloon Guide Catheter
Applicant
MicroVention, Inc.
35 Enterprise
Aliso Viejo,  CA  92656
Applicant Contact Stephanie Onstot
Correspondent
MicroVention, Inc.
1311 Valencia Avenue
Tustin,  CA  92780
Correspondent Contact Stephanie Onstot
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
QJP  
Date Received12/26/2019
Decision Date 07/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-