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 neurological stereotaxic instrument
510(k) Number K141559
Device Name V-GUIDE FOR VENTRICULOSTOMIES
Applicant
ARC SURGICAL LLC.
1135 W NASA BLVD STE 500
MELBOURNE,  FL  32901
Applicant Contact CRAIG PAGAN
Correspondent
ARC SURGICAL LLC.
1135 W NASA BLVD STE 500
MELBOURNE,  FL  32901
Correspondent Contact CRAIG PAGAN
Regulation Number882.4560
Classification Product Code
HAW  
Date Received06/12/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-