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510(k) K923594

CLOTTRAC COAGULATION CONTROL by Medtronic Hemotec, Inc. — Product Code JBP

K923594 is an FDA 510(k) premarket notification submitted by Medtronic Hemotec, Inc. for the device "CLOTTRAC COAGULATION CONTROL". The FDA issued a decision of Substantially Equivalent on September 21, 1992. The device falls under product code JBP (Activated Whole Blood Clotting Time), a Class II device regulated under 21 CFR 864.7140. Medtronic Hemotec, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1992
Date Received
July 20, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Activated Whole Blood Clotting Time
Device Class
Class II
Regulation Number
864.7140
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)
  • K922031 — HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (July 21, 1992)

Other clearances for product code JBP

  • K223635 — Sonoclot Coagulation & Platelet Function Analyzer System with Sonoclot Viewer (January 4, 2023)
  • K062604 — RAPIDTEG TEG-ACT TEST (January 31, 2007)
  • K032952 — AIACT KIT (December 12, 2003)
  • K023582 — I-STAT KAOLIN ACT TEST (September 8, 2003)
  • K020914 — ACTALYKE XL ACTIVATED CLOTTING TIME ANALYZER, MODEL 5770 (May 23, 2002)
  • K013078 — ACTALYKE MINI ACTIVATED CLOTTING TIME TEST SYSTEM, MODEL 5750/5752 (January 10, 2002)
  • K002528 — SONOCLOT COAGULATION & PLATELET FUNCTION ANALYZER SYSTEM WITH SIGNATURE VIEWER O (August 31, 2000)
  • K994194 — (TAS) LOW RANGE HEPARIN MANAGEMENT CARD RAPIDPOINT (March 28, 2000)
  • K992571 — I-STAT SYSTEM (February 10, 2000)
  • K992851 — ACT TEST CATRIDGES FOR COAGUCHEK PRO SYSTEM, ACT CONTROLS FOR COAGUCHEK PRO SYST (January 14, 2000)

FDA data resources