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FDA 510(k) Application Details - K133569
Device Classification Name
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510(K) Number
K133569
Device Name
TRUE DILATATION BALLOON VALVULOPLASTY CATHETER, 20MM X 4.5 CM, 22MM X 4.5CM, 24 MM X 4.5CM, 26MM X 4.5CM
Applicant
BARD PERIPHERAL VASCULAR, INC.
1307 SOUTH MARY AVENUE
SUITE 280
SUNNYVALE, CA 94087 US
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TIFFINI DIAGE
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Regulation Number
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Classification Product Code
OZT
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Date Received
11/20/2013
Decision Date
12/20/2013
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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