FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ESCHMANN DILATION CATHETER
K Number: K833742
·
Decision Apr 24, 1984
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
21
Review Days
181
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Basic Information
- Device Name
- ESCHMANN DILATION CATHETER
- K Number
- K833742
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Vertex Medical Corp.
- Date Received
- October 26, 1983
- Decision Date
- April 24, 1984
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
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| K Number | Device Name | ||
|---|---|---|---|
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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 |
| K823254 | REUSABLE METAL STOPCOCK | Dec 30, 1982 | Substantially Equivalent |