FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
K Number: K820410
·
Decision Apr 9, 1982
Classifications
1
FEI Numbers
76
Registration Numbers
76
Same Product Code
85
Applicant Total
15
Review Days
56
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Basic Information
- Device Name
- HEMOTEC HEPCON/SYSTEM FOUR & FOUR P
- K Number
- K820410
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.5100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Hemotec, Inc.
- Date Received
- February 12, 1982
- Decision Date
- April 9, 1982
- Product Code
- LOX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Hemotec, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K902081 | CLOTTRAC(TM) IBEX HEPARINASE HR ACT CART./CONTROL | Jul 3, 1990 | Substantially Equivalent |
| K894359 | CLOTRAC CITRATED WHOLE BLOOD COAGULATION CONTROLS | Sep 5, 1989 | Substantially Equivalent |
| K894317 | HEMOTEC HEPCON HMS COAGULATION SYSTEM & ACCESS. | Sep 5, 1989 | Substantially Equivalent |
| K894466 | HEPCON(R) CV WHOLE BLOOD COAGULATION CONTROLS | Sep 5, 1989 | Substantially Equivalent |
| K884590 | HEPCON/SYSTEM B-10 HEPARIN ASSAY/SCREEN/CARTRIDGES | Jan 10, 1989 | Substantially Equivalent |
| K875089 | HEPCON SYSTEM B-10 ACTIVATED CLOT TIME & HEPARIN | Mar 9, 1988 | Substantially Equivalent |
| K880302 | CALCIUM CHLORIDE SOLUTION 0.1M, IN HEPES BUFFER | Feb 19, 1988 | Substantially Equivalent |
| K854377 | HEMOTEC CV WHOLE BLOOD COAGULATION CONTROLS | Dec 4, 1985 | Substantially Equivalent |
| K854376 | HEMOTEC CITRATED WHOLE BLOOD COAGULATION CONTROLS | Dec 4, 1985 | Substantially Equivalent |
| K853789 | ADDITIONAL HEMOTEC HEPCON/SYS B-10 COAGULATION CAR | Oct 4, 1985 | Substantially Equivalent |