FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SURFLO WINGED INFUSION SET
K Number: K771204
·
Decision Jul 14, 1977
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
31
Review Days
9
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Basic Information
- Device Name
- SURFLO WINGED INFUSION SET
- K Number
- K771204
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Terumo America, Inc.
- Date Received
- July 5, 1977
- Decision Date
- July 14, 1977
- Product Code
- FPA
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FPA | Set, Administration, Intravascular | FDA class 2 | General Hospital |
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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 |