FDA 510(k) Application Details - K082094

Device Classification Name Wire, Guide, Catheter

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510(K) Number K082094
Device Name Wire, Guide, Catheter
Applicant C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION
55 TECHNOLOGY DR.
LOWELL, MA 01851 US
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Contact DEBORAH L HERRINGTON
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Regulation Number 870.1330

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Classification Product Code DQX
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Date Received 07/24/2008
Decision Date 12/17/2008
Decision SESE - SUBST EQUIV
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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