FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GUIDE WIRE
K Number: K822597
·
Decision Sep 21, 1982
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
21
Review Days
25
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Basic Information
- Device Name
- GUIDE WIRE
- K Number
- K822597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vertex Medical Corp.
- Date Received
- August 27, 1982
- Decision Date
- September 21, 1982
- Product Code
- DQX
- 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 |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Vertex Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833742 | ESCHMANN DILATION CATHETER | Apr 24, 1984 | Substantially Equivalent |
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| K832380 | PROTECTIVE SLEEVE | Nov 28, 1983 | Substantially Equivalent |
| K831666 | SIALOGRAPHY NEEDLE | Jul 12, 1983 | Substantially Equivalent |
| K830576 | LYMPHANGIOGRAPHY SET | Mar 17, 1983 | Substantially Equivalent |
| K830420 | POLYETHYLENE MONITORING CONNECTORS | Feb 28, 1983 | Substantially Equivalent |
| K830237 | TRANSLUCENT POLY. CATH. CONNECTOR AND | Feb 18, 1983 | Substantially Equivalent |
| K823192 | TUOHY-BORST ADAPTER W/SIDE ARM | Dec 30, 1982 | Substantially Equivalent |
| K823253 | VERTEX MONITORING CATHETER | Dec 30, 1982 | Substantially Equivalent |
| K823256 | ULTRA-ASEPT ANGIOGRAPHIC SYRINGE/SPARE | Dec 30, 1982 | Substantially Equivalent |