FDA 510(k) Application Details - K933517

Device Classification Name Wire, Guide, Catheter

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510(K) Number K933517
Device Name Wire, Guide, Catheter
Applicant CARDIOVASCULAR IMAGING SYSTEMS, INC.
595 NORTH PASTORIA AVE.
SUNNYVALE, CA US
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Contact YUE-TEH JANG
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/20/1993
Decision Date 10/15/1993
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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