FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIPHERAL ATHERECTOMY SYSTEM
K Number: K890515
·
Decision May 23, 1989
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
13
Applicant Total
12
Review Days
111
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Basic Information
- Device Name
- PERIPHERAL ATHERECTOMY SYSTEM
- K Number
- K890515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4875
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Intensive Technology, Inc.
- Date Received
- February 1, 1989
- Decision Date
- May 23, 1989
- Product Code
- DWX
- 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 |
|---|---|---|---|
| DWX | Stripper, Artery, Intraluminal | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DWX), ordered by most recent decision date.
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MOLLRING CUTTER
FDA 510(k)
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EXTERNAL VEIN STRIPPER
FDA 510(k)
FDA Class 2
·Cardiovascular
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 |
| K892209 | APTT BY HEMOCHRON(R) | Jun 22, 1989 | Substantially Equivalent |
| K882804 | 0.014 PERIPHERAL GUIDE WIRE | Oct 28, 1988 | Substantially Equivalent |