FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ARGYLE PEDIATRIC VENA CAVAL CATHETER
K Number: K791972
·
Decision Oct 11, 1979
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
393
Applicant Total
191
Review Days
9
Basic Information
- Device Name
- ARGYLE PEDIATRIC VENA CAVAL CATHETER
- K Number
- K791972
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- SHERWOOD MEDICAL CO.
- Date Received
- October 2, 1979
- Decision Date
- October 11, 1979
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K954525 | SENSI-TOUCH EPIDURAL ANESTHESIA FILTER | Jan 19, 1996 | Substantially Equivalent |
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