Atlas FDA

HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX

FDA 510(k) clearance K101271 · decided 2010-10-13

Clearance details

K-number
K101271
Device name
HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX
Applicant
Medtronic, Inc.
Decision
Substantially Equivalent
Date received
2010-05-06
Decision date
2010-10-13
Days to decision
160 days
Clearance type
Special
Product code
JOX
Device class
2
Regulation number
864.5680
Medical specialty
Hematology
Advisory committee
Hematology
Location
Mounds View, MN, 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
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 HEPCON HMS COAGULATION SYSTEM & ACCESS. (K894317)Hemotec, Inc.1989-09-05
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

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
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Activa™ Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense™ (P960009/S524)Medtronic, Inc.2025-12-08