FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
LYMPHANGIOGRAPHY SET
K Number: K830576
·
Decision Mar 17, 1983
Classifications
1
FEI Numbers
210
Registration Numbers
211
Same Product Code
499
Applicant Total
21
Review Days
22
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Basic Information
- Device Name
- LYMPHANGIOGRAPHY SET
- K Number
- K830576
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1200
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Vertex Medical Corp.
- Date Received
- February 23, 1983
- Decision Date
- March 17, 1983
- Product Code
- DQO
- 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 |
|---|---|---|---|
| DQO | Catheter, Intravascular, Diagnostic | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQO), ordered by most recent decision date.
Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
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Other Clearances by Vertex Medical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K833742 | ESCHMANN DILATION CATHETER | Apr 24, 1984 | Substantially Equivalent |
| K834476 | NEPHROSTOMY/BILIARY DRAINAGE BAG | Feb 4, 1984 | Substantially Equivalent |
| K832380 | PROTECTIVE SLEEVE | Nov 28, 1983 | Substantially Equivalent |
| K831666 | SIALOGRAPHY NEEDLE | Jul 12, 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 |