FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMOCLAV VENOUS CATHETER
K Number: K831801
·
Decision Jul 7, 1983
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
22
Applicant Total
5
Review Days
34
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Basic Information
- Device Name
- HEMOCLAV VENOUS CATHETER
- K Number
- K831801
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Exo, Inc.
- Date Received
- June 3, 1983
- Decision Date
- July 7, 1983
- Product Code
- FIQ
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| FIQ | Cannula, A-V Shunt | FDA class 2 | Gastroenterology, Urology |
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