Home / 510(k) Clearances / K012749

510(k) K012749

BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 by Biocardia, Inc. — Product Code DQO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 24, 2002
Date Received
August 16, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Biocardia, Inc.

  • K242169 — Morph DNA Steerable Introducer Sheath (August 23, 2024)
  • 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)

Other clearances for product code DQO

  • K250751 — DualView Catheter (July 17, 2025)
  • K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter (January 31, 2025)
  • K242420 — pNOVUS 21 Microcatheter (November 12, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K233975 — Zoom 6F Insert Catheters (April 2, 2024)
  • K232536 — Soldier Microcatheter (February 23, 2024)
  • K232573 — INFINITI™ Ambi Angiographic Catheter (November 21, 2023)
  • K230620 — Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging Catheter (August 8, 2023)
  • K231293 — Drakon™ and Sequre® Microcatheters (June 1, 2023)
  • K230411 — Dragonfly OpStar™ Imaging Catheter (April 14, 2023)