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FDA 510(k) Application Details - K180986
Device Classification Name
Catheter, Percutaneous
More FDA Info for this Device
510(K) Number
K180986
Device Name
Catheter, Percutaneous
Applicant
XableCath, Inc.
417 South Wakara Way, Suite 3510
Salt Lake City, UT 84108-1457 US
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Contact
Rick Gaykowski
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
04/16/2018
Decision Date
05/15/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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