FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMODIALYSIS FISTULA SET
K Number: K770864
·
Decision Jun 24, 1977
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
14
Review Days
44
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Basic Information
- Device Name
- HEMODIALYSIS FISTULA SET
- K Number
- K770864
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Venospital, Inc.
- Date Received
- May 11, 1977
- Decision Date
- June 24, 1977
- Product Code
- FIE
- 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 |
|---|---|---|---|
| FIE | Needle, Fistula | FDA class 2 | Gastroenterology, Urology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FIE), ordered by most recent decision date.
JMS CAVEO A.V. Fistula Needle Set
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FDA Class 2
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DORA Disposable A.V. Fistula Needle Sets
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Dimesol Disposable AV Fistula Needle Set (Non-Safety Series) and Dimesol Disposable AV Fistula Needle Set (Safety Series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
DORA Disposable A.V. Fistula Needle Sets
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
JMS Harmony A.V. Fistula Needle Set
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
ANGEL TIP SAFETY INTRAVASCULAR NEEDLE SET
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Other Clearances by Venospital, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791130 | FLU-VEN TK-2 | Sep 4, 1979 | Substantially Equivalent |
| K791131 | FLU VEN TR-1 | Sep 4, 1979 | Substantially Equivalent |
| K790077 | BIOSTIL # 3884 | Apr 30, 1979 | Substantially Equivalent |
| K790424 | FLU-VEN 01510 | Apr 30, 1979 | Substantially Equivalent |
| K781186 | INFUSION, VENOTHIN 23 | Aug 10, 1978 | Substantially Equivalent |
| K781187 | INFUSION SET W/ INJECTION SITE, 23D-W | Aug 10, 1978 | Substantially Equivalent |
| K781185 | INFUSION SET W/ INJECTION SITE | Aug 10, 1978 | Substantially Equivalent |
| K781188 | INFUSION SET, VENOTHIN 25 | Aug 10, 1978 | Substantially Equivalent |
| K781184 | INFUSION SET, VENOTHIN 19 | Aug 10, 1978 | Substantially Equivalent |
| K781190 | INFUSION SET, VENOTHIN 21 | Aug 10, 1978 | Substantially Equivalent |