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510(k) K042553

BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER by Biocardia, Inc. — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2005
Date Received
September 20, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
Submission Type

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  • K090999 — BIOCARDIA MORPH SHEATH GUIDE (April 15, 2009)
  • K012749 — BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 (January 24, 2002)

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