FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SARNS 9000 UNIVERSAL ROLLER PUMP
K Number: K953904
·
Decision Apr 19, 1996
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
20
Applicant Total
49
Review Days
245
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Basic Information
- Device Name
- SARNS 9000 UNIVERSAL ROLLER PUMP
- K Number
- K953904
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4370
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Health Care, Ltd.
- Date Received
- August 18, 1995
- Decision Date
- April 19, 1996
- Product Code
- DWB
- 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 |
|---|---|---|---|
| DWB | Pump, Blood, Cardiopulmonary Bypass, Roller Type | FDA class 2 | Cardiovascular |
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|---|---|---|---|
| K926364 | ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X | Mar 31, 1995 | Substantially Equivalent |
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| K941748 | STERI-VAC GAS STERILIZER MODEL 8XL | Dec 2, 1994 | Substantially Equivalent |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | Feb 10, 1994 | Substantially Equivalent |
| K932307 | 3M MAXI-DRIVER II DBATTERY POWERED SYSTEM | Jan 7, 1994 | Substantially Equivalent |
| K932422 | 3M TEGADERM HP TRANSPARENT DRESSING | Dec 27, 1993 | Substantially Equivalent |
| K932446 | INJECTION SITE | Nov 29, 1993 | Substantially Equivalent |
| K931968 | CDI 100 EXTRACORPOREAL HEMATOCRIT/OXYGEN SATURATIO | Nov 10, 1993 | Substantially Equivalent |
| K933006 | AVI INFUSION PUMPS, ADDITIONAL INTENDED USE | Oct 25, 1993 | Substantially Equivalent |
| K933005 | AVI MODEL 600 SYRINGE PUMP | Oct 25, 1993 | Substantially Equivalent |