FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
APTT BY HEMOCHRON(R)
K Number: K892209
·
Decision Jun 22, 1989
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
51
Applicant Total
12
Review Days
80
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Basic Information
- Device Name
- APTT BY HEMOCHRON(R)
- K Number
- K892209
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Intensive Technology, Inc.
- Date Received
- April 3, 1989
- Decision Date
- June 22, 1989
- Product Code
- GFO
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| GFO | Activated Partial Thromboplastin | FDA class 2 | Hematology |
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Other Clearances by Intensive Technology, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922970 | INTRA-OPERATIVE TEC ATHERECTOMY SYSTEM | Jan 13, 1993 | Substantially Equivalent |
| K912664 | TEC ROTATING DUAL HEMOVALVE | Aug 24, 1992 | Substantially Equivalent |
| K911869 | IVT GUIDING CATHETER | Oct 16, 1991 | Substantially Equivalent |
| K903463 | IVT INTRODUCER SHEATH | Jan 3, 1991 | Substantially Equivalent |
| K904003 | HEMOCHRON(R) HEPARIN RESPONSE TEST | Nov 29, 1990 | Substantially Equivalent |
| K901767 | MODIFIED IVT PERIPHERAL ATHERECTOMY | Jun 28, 1990 | Substantially Equivalent |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | Mar 6, 1990 | Substantially Equivalent |
| K895903 | IVT 0.014 GUIDE WIRE | Jan 4, 1990 | Substantially Equivalent |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | May 23, 1989 | Substantially Equivalent |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | Oct 28, 1988 | Substantially Equivalent |