HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20— 510(k) K042070

Name: FDA 510(k) clearance K042070
Creator: U.S. Food and Drug Administration
Published: 2004-10-01

Substantially Equivalent

Medtronic Vascular

FDA 510(k) clearance K042070 for HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20, Substantially Equivalent on 2004-10-01. Applicant: Medtronic Vascular. Device class: 2.

Clearance details

Applicant: Medtronic Vascular
Product code: Code JOX
Device class: Class 2
Regulation: 21 CFR 864.5680
Advisory panel: Hematology
Date received: 2004-08-02
Decision date: 2004-10-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JOX

view all

K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)2011-06-08
K102953 — HEPARIN DOSE RESPONSE CARTRIDGE2010-11-04
K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX2010-10-13
K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR2005-05-24
K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR2004-12-03

More clearances from Medtronic Vascular

view all

Data sourced from openFDA. This site is unofficial and independent of the FDA.