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 Name | NEUROFLO CATHETER 7F |
Classification Name | catheter, neurovasculature, occluding balloon |
Generic Name | catheter, neurovasculature, occluding balloon |
Regulation Number | 882.5150 |
Applicant |
ZOLL CIRCULATION |
2000 ringwood ave |
san jose, CA 95131 |
|
HDE Number | H030005 |
Supplement Number | S003 |
Date Received | 07/22/2014 |
Decision Date | 10/03/2014 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at matrix medtech inc. , in maple grove, minnesota. |
|
|