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510(k) K090999

BIOCARDIA MORPH SHEATH GUIDE by Biocardia, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 15, 2009
Date Received
April 8, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

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  • K012749 — BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 (January 24, 2002)

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