Product code JOX
- Device name
- Analyzer, Heparin, Automated
- Medical specialty
- Hematology
- Device class
- 2
- Regulation number
- 864.5680
- Review panel
- HE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111339 | HEMOSTASIS MANAGMENT SYSTEM PLUS (HMS-PLUS) | Medtronic, Inc. | 2011-06-08 |
| K102953 | HEPARIN DOSE RESPONSE CARTRIDGE | Medtronic, Inc. | 2010-11-04 |
| K101271 | HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX | Medtronic, Inc. | 2010-10-13 |
| K051040 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Perfusion Systems | 2005-05-24 |
| K043080 | HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR | Medtronic Vascular | 2004-12-03 |
| K042070 | HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 | Medtronic Vascular | 2004-10-01 |
| K993519 | RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST | Cardiovascular Diagnostics, Inc. | 2000-01-14 |
| K922031 | HMS PURPLE AND BLACK HEPARIN CARTRIDGES & CONTROL | Medtronic Hemotec, Inc. | 1992-07-21 |
| K911240 | HEPCON HMS WITH BODY SURFACE AREA CALCULATION | Hemotech, Inc. | 1991-07-17 |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Hemotec, Inc. | 1989-09-05 |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Hemotec, Inc. | 1985-12-04 |
| K841021 | HEMOTEC, HEPCON/SYS B-10 HEPARIN/PROTAM | Hemotec, Inc. | 1984-05-25 |
| K830665 | HEPCOL SYSTEM B-10 & B-10-P | Hemotec, Inc. | 1983-06-08 |
| K813011 | HEPAQUANT | Streck Laboratories, Inc. | 1982-01-26 |
| K800161 | HEPCON/SYSTEM RC-10 | Hemotec, Inc. | 1980-03-19 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 20643169713240 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713185 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713178 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713161 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713154 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713147 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713192 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713208 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713215 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713222 | N/A | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713239 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713246 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713233 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713226 | N/A | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713219 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713202 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713196 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713189 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713172 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713165 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713158 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 20643169713141 | NA | MEDTRONIC, INC. | 2023-04-08 |
| 00643169713253 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20763000014791 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20763000014784 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20763000014777 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20763000014760 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20763000014753 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 20643169713257 | N/A | MEDTRONIC, INC. | 2021-11-12 |
| 10721902843010 | NA | MEDTRONIC, INC. | 2016-06-13 |