FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IV SETS 2000 SERIES (HS-200,2L0,220)
K Number: K761327
·
Decision Jan 31, 1977
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
69
Review Days
35
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Basic Information
- Device Name
- IV SETS 2000 SERIES (HS-200,2L0,220)
- K Number
- K761327
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Extracorporeal Medical Specialities, Inc.
- Date Received
- December 27, 1976
- Decision Date
- January 31, 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 Extracorporeal Medical Specialities, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K843955 | EXTRACORPOREAL MAXIMA HOLLOW FIBER OXYGENATOR | Nov 29, 1984 | Substantially Equivalent |
| K840532 | HEMOPERFUSION SYSTEM TP-400 | May 30, 1984 | Substantially Equivalent |
| K840262 | HANCOCK PERICARDIAL PATCH | May 30, 1984 | Substantially Equivalent |
| K840146 | EXP* 700 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K840057 | EXP* 500 PARALLEL PLATE DIALYZER | Feb 4, 1984 | Substantially Equivalent |
| K831423 | THERAPEUTIC EXCHANGE SYSTEM | Jan 3, 1984 | Substantially Equivalent |
| K832547 | ULTRAFILTRATION CONTROLLER | Jan 3, 1984 | Substantially Equivalent |
| K833477 | INTERSEPT 40 MICRON FILTER | Dec 27, 1983 | Substantially Equivalent |
| K833476 | INTERSEPT 40 MICRON FILTER W/TUBING | Dec 27, 1983 | Substantially Equivalent |
| K831424 | THERAPEUTIC EXCHANGE BLOOD TUBING-TP-101 | Oct 14, 1983 | Substantially Equivalent |