Cleared Special

HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20

K042070 · Medtronic Vascular · Hematology
Oct 2004
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K042070 is an FDA 510(k) clearance for the HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20, a Analyzer, Heparin, Automated (Class II — Special Controls, product code JOX), submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on October 1, 2004, 60 days after receiving the submission on August 2, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5680.

Submission Details

510(k) Number K042070 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 2004
Decision Date October 01, 2004
Days to Decision 60 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JOX — Analyzer, Heparin, Automated
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5680

Similar Devices — JOX Analyzer, Heparin, Automated

All 14
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)
K111339 · Medtronic, Inc. · Jun 2011
HEPARIN DOSE RESPONSE CARTRIDGE
K102953 · Medtronic, Inc. · Nov 2010
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
K101271 · Medtronic, Inc. · Oct 2010
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K051040 · Medtronic Perfusion Systems · May 2005
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR
K043080 · Medtronic Vascular · Dec 2004
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
K993519 · Cardiovascular Diagnostics, Inc. · Jan 2000

More from Medtronic Vascular

View all
Steerant? Super Stiff Guidewire
K232570 · DQX · Oct 2023
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
K232190 · DQY · Aug 2023
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
K230156 · DQY · Jun 2023
Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)
K220773 · MAV · Apr 2022
Medtronic 6F Taiga Guiding Catheter
K192296 · DQY · Sep 2019