FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AV FISTULA NEEDLE SET
K Number: K771206
·
Decision Jul 15, 1977
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
78
Applicant Total
31
Review Days
10
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Basic Information
- Device Name
- AV FISTULA NEEDLE SET
- K Number
- K771206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5540
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Terumo America, Inc.
- Date Received
- July 5, 1977
- Decision Date
- July 15, 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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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)
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DORA Disposable A.V. Fistula Needle Sets
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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 Terumo America, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K811523 | PLASMA FLEX | Sep 9, 1981 | Substantially Equivalent |
| K802970 | TERUMO HOLLOW FIBER OXYGENATOR | Jan 22, 1981 | Substantially Equivalent |
| K802441 | CLIRANS TH10 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K802122 | CLIRANS TH13 HOLLOW FIBER DIALYZER | Dec 18, 1980 | Substantially Equivalent |
| K801192 | CLIRANS TE10 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801193 | CLIRANS TE15 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K801194 | CLIRANS TE07 HOLLOW FIBER DIALYZER | Aug 12, 1980 | Substantially Equivalent |
| K791411 | COAXIAL DUAL FLOW CATHETER | Nov 13, 1979 | Substantially Equivalent |
| K791173 | SURFLO INJECTION PLUG | Jul 30, 1979 | Substantially Equivalent |
| K790105 | TERUMO IMUGARD | May 24, 1979 | Substantially Equivalent |