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510(k) K922031

HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL by Medtronic Hemotec, Inc. — Product Code JOX

K922031 is an FDA 510(k) premarket notification submitted by Medtronic Hemotec, Inc. for the device "HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL". The FDA issued a decision of Substantially Equivalent on July 21, 1992. The device falls under product code JOX (Analyzer, Heparin, Automated), a Class II device regulated under 21 CFR 864.5680. Medtronic Hemotec, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1992
Date Received
May 1, 1992
Clearance Type
Traditional
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

Other clearances by Medtronic Hemotec, Inc.

  • K954202 — PLATELET FUNCTION TEST ASSAY CARTRIDGES FOR THE HEPCON HMS (June 20, 1996)
  • K944115 — HEPARIN ASSAY CARTRIDGES AND CONTROLS (March 24, 1995)
  • K940426 — MEDTRONIC HEMOTEC ACT II AUTOMATED COAGULATION TIMER (September 20, 1994)
  • K923594 — CLOTTRAC COAGULATION CONTROL (September 21, 1992)

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)
  • 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)
  • 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