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510(k) K242169

Morph DNA Steerable Introducer Sheath by Biocardia — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 23, 2024
Date Received
July 24, 2024
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Biocardia

  • K192774 — BioCardia 8F Morph DNA Deflectable Guide Catheter (January 7, 2020)
  • K190941 — BioCardia 8.5 F Avance Steerable lntroducer (May 6, 2019)
  • K090999 — BIOCARDIA MORPH SHEATH GUIDE (April 15, 2009)
  • K042553 — BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER (February 17, 2005)
  • K012749 — BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 (January 24, 2002)

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