FDA 510(k) Application Details - K941706

Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal

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510(K) Number K941706
Device Name Catheter, Angioplasty, Peripheral, Transluminal
Applicant VAS-CATH, INC.
2380 TEDLO ST.
MISSISSAUGA, ONTARIO L5A 3V3 CA
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Contact ANGELA J ACITO
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Regulation Number 870.1250

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Classification Product Code LIT
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Date Received 04/06/1994
Decision Date 10/18/1994
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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