RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
FDA 510(k) clearance K993519 · decided 2000-01-14
Clearance details
- K-number
- K993519
- Device name
- RAPIDPOINT ACCENT, MODEL 2000, RAPIDPOINT COAG HEPARIN TITRATION TEST, RAPIDPOINT COAG PROTAMINE RESPONSE TEST
- Applicant
- Cardiovascular Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-18
- Decision date
- 2000-01-14
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- JOX
- Device class
- 2
- Regulation number
- 864.5680
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Raleigh, NC, 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.
| Record | Firm | Date |
|---|---|---|
| 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 Systems | 2005-05-24 |
| HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR (K043080) | Medtronic Vascular | 2004-12-03 |
| HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 (K042070) | Medtronic Vascular | 2004-10-01 |
| 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.