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HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.

FDA 510(k) clearance K894317 · decided 1989-09-05

Clearance details

K-number
K894317
Device name
HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS.
Applicant
Hemotec, Inc.
Decision
Substantially Equivalent
Date received
1989-07-14
Decision date
1989-09-05
Days to decision
53 days
Clearance type
Traditional
Product code
JOX
Device class
2
Regulation number
864.5680
Medical specialty
Hematology
Advisory committee
Hematology
Location
Englewood, CO, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) (K111339)Medtronic, Inc.2011-06-08
HEPARIN DOSE RESPONSE CARTRIDGE (K102953)Medtronic, Inc.2010-11-04
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX (K101271)Medtronic, Inc.2010-10-13
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K051040)Medtronic Perfusion Systems2005-05-24
HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K043080)Medtronic Vascular2004-12-03
HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (K042070)Medtronic Vascular2004-10-01
RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST (K993519)Cardiovascular Diagnostics, Inc.2000-01-14
HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL (K922031)Medtronic Hemotec, Inc.1992-07-21
HEPCON HMS WITH BODY SURFACE AREA CALCULATION (K911240)Hemotech, Inc.1991-07-17
HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS (K854377)Hemotec, Inc.1985-12-04
HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM (K841021)Hemotec, Inc.1984-05-25
HEPCOL SYSTEM B-10 & B-10-P (K830665)Hemotec, Inc.1983-06-08

Recalls involving this device

RecordFirmDate
Medtronic HMS PLUS, Hemostasis Management System, Model 30514. It is a microprocessor base recall (Z-1070-2010)Medtronic Inc2010-03-11