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 Occluder, Catheter Tip
510(k) Number K945963
Device Name THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
Applicant
Micro Interventional Systems, Inc.
680 W. Maude Ave.
Suite Two
Sunnyvale,  CA  94086
Applicant Contact MARIA CARRILLO
Correspondent
Micro Interventional Systems, Inc.
680 W. Maude Ave.
Suite Two
Sunnyvale,  CA  94086
Correspondent Contact MARIA CARRILLO
Regulation Number870.1370
Classification Product Code
DQT  
Date Received12/07/1994
Decision Date 02/08/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-