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

Humanitarian Device Exemption (HDE)
  • 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
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
Trade NameCOAXIA NEUROFLO CATHETER
Classification Namecatheter, neurovasculature, occluding balloon
Generic Namecatheter, neurovasculature, occluding balloon
Regulation Number882.5150
Applicant
ZOLL CIRCULATION
2000 ringwood ave
san jose, CA 95131
HDE NumberH030005
Supplement NumberS001
Date Received03/30/2006
Decision Date09/08/2006
Product Code
NUF
Advisory Committee Neurology
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the neuro~lo instructions for use manual. The device labeling, as modified, will be marketed under the trade name coaxia neuirofloperfusion augmentation catheter model 10 17 and is indicated for the treatment of cerebral isehemnia resulting from symptomatic vasospasmn following anleurismnal subarachnoid hemorrhage. Secured by either surgical oi endovascular intervention prior to neuroflo catheter treatment.
-
-