Home / 510(k) Clearances / K192774

510(k) K192774

BioCardia 8F Morph DNA Deflectable Guide Catheter by Biocardia — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2020
Date Received
September 30, 2019
Clearance Type
Special
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

Other clearances by Biocardia

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

Other clearances for product code DQY

  • K260499 — Amplatzer™ Trevisio™ Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609- (March 13, 2026)
  • K253409 — C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320 (December 19, 2025)
  • K252417 — Amplatzer Piccolo™ Delivery System (9-PDS-04F-045) (December 17, 2025)
  • K252390 — Telescope Guide Extension Catheter (October 29, 2025)
  • K250147 — CPS Locator 3D Delivery Catheter (August 22, 2025)
  • K251277 — CoraForce Microcatheter, CoraFlex Microcatheter (August 22, 2025)
  • K250972 — Primum Hydrophilic Guiding Catheter (June 29, 2025)
  • K250828 — CPS Locator 3D Plus Delivery Catheter (June 27, 2025)
  • K243184 — SAT CenterFlow Molding Balloon Catheter (IN20-00313) (June 25, 2025)
  • K250492 — FlexiGo 3D Delivery Catheter (June 18, 2025)