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510(k) K111339

HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) by Medtronic, Inc. — Product Code JOX

K111339 is an FDA 510(k) premarket notification submitted by Medtronic, Inc. for the device "HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS)". The FDA issued a decision of Substantially Equivalent on June 8, 2011. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680. Medtronic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2011
Date Received
May 12, 2011
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

  • K102953 — HEPARIN DOSE RESPONSE CARTRIDGE (November 4, 2010)
  • K101271 — HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (October 13, 2010)
  • K051040 — HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (May 24, 2005)
  • 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)

FDA data resources