FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX
K Number: K844229
·
Decision Jan 14, 1985
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
168
Applicant Total
75
Review Days
74
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Basic Information
- Device Name
- VENOUS RESERVOIR VRS-XXX SERIES; HOLDER VRS-HXX
- K Number
- K844229
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4400
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Gish Biomedical, Inc.
- Date Received
- November 1, 1984
- Decision Date
- January 14, 1985
- Product Code
- DTN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DTN | Reservoir, Blood, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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| K Number | Device Name | ||
|---|---|---|---|
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| K090450 | MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LT | Sep 18, 2009 | Substantially Equivalent |
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| 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 |