FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INTRAVASCULAR ADMINISTRATION SET
K Number: K833030
·
Decision Nov 3, 1983
Classifications
1
FEI Numbers
424
Registration Numbers
424
Same Product Code
1173
Applicant Total
75
Review Days
57
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Basic Information
- Device Name
- INTRAVASCULAR ADMINISTRATION SET
- K Number
- K833030
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5440
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Gish Biomedical, Inc.
- Date Received
- September 7, 1983
- Decision Date
- November 3, 1983
- 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 Gish Biomedical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K090449 | MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LT | Sep 18, 2009 | Substantially Equivalent |
| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | Sep 18, 2009 | Substantially Equivalent |
| K091062 | MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730 | Aug 4, 2009 | Substantially Equivalent |
| K083131 | MEDOS HILITE RESERVOIR, MODEL: 4030 | Jul 30, 2009 | Substantially Equivalent |
| K082403 | MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT | May 15, 2009 | Substantially Equivalent |
| K082082 | GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K081947 | GISH CAPVRF44 HARDSHELL VENOUS RESERVOIR WITH HA COATING | Feb 4, 2009 | Substantially Equivalent |
| K080708 | VISION HOLLOW FIBER OXYGENATOR WITH HA COATING | Feb 2, 2009 | Substantially Equivalent |
| K081838 | GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING | Jan 26, 2009 | Substantially Equivalent |
| K081881 | GISH TUBING AND CONNECTORS WITH HA COATING | Jan 23, 2009 | Substantially Equivalent |