FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFIED IVT PERIPHERAL ATHERECTOMY
K Number: K901767
·
Decision Jun 28, 1990
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
402
Applicant Total
12
Review Days
72
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Basic Information
- Device Name
- MODIFIED IVT PERIPHERAL ATHERECTOMY
- K Number
- K901767
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intensive Technology, Inc.
- Date Received
- April 17, 1990
- Decision Date
- June 28, 1990
- Product Code
- LIT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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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 |
| K896403 | MODIFIED IVT PERIPHERAL ATHERECTOMY SYSTEM | Mar 6, 1990 | Substantially Equivalent |
| K895903 | IVT 0.014 GUIDE WIRE | Jan 4, 1990 | Substantially Equivalent |
| K892209 | APTT BY HEMOCHRON(R) | Jun 22, 1989 | Substantially Equivalent |
| K890515 | PERIPHERAL ATHERECTOMY SYSTEM | May 23, 1989 | Substantially Equivalent |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | Oct 28, 1988 | Substantially Equivalent |