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510(k) K051040

HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR by Medtronic Perfusion Systems — Product Code JOX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 24, 2005
Date Received
April 25, 2005
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Heparin, Automated
Device Class
Class II
Regulation Number
864.5680
Review Panel
HE
Submission Type

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Other clearances for product code JOX

  • K111339 — HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (June 8, 2011)
  • K102953 — HEPARIN DOSE RESPONSE CARTRIDGE (November 4, 2010)
  • K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (October 13, 2010)
  • K043080 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (December 3, 2004)
  • K042070 — HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (October 1, 2004)
  • K993519 — RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOIN (January 14, 2000)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)
  • K911240 — HEPCON HMS WITH BODY SURFACE AREA CALCULATION (July 17, 1991)
  • K894317 — HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. (September 5, 1989)
  • K854377 — HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (December 4, 1985)