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. |
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Trade Name | COAXIA NEUROFLO CATHETER |
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 |
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HDE Number | H030005 |
Supplement Number | S002 |
Date Received | 07/22/2008 |
Decision Date | 10/16/2008 |
Product Code | |
Advisory Committee |
Neurology |
Supplement Type | normal 75 day track |
Supplement Reason | change design/components/specifications/material |
Expedited Review Granted? | No |
Combination Product | No |
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