FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
K Number: K902671
·
Decision Jul 17, 1990
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
194
Applicant Total
77
Review Days
29
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Basic Information
- Device Name
- COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER
- K Number
- K902671
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5830
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Cobe Laboratories, Inc.
- Date Received
- June 18, 1990
- Decision Date
- July 17, 1990
- Product Code
- CAC
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| CAC | Apparatus, Autotransfusion | FDA class 2 | Anesthesiology |
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Other Clearances by Cobe Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | May 11, 1993 | Substantially Equivalent |
| K900105 | COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC | Mar 22, 1991 | Substantially Equivalent |
| K905793 | COBE CENTRY 2 BICART OPTION KIT | Feb 12, 1991 | Substantially Equivalent |
| K905388 | COBE CENTRYSYSTEM 3 BICART OPTION KIT | Feb 11, 1991 | Substantially Equivalent |
| K904336 | NEW COBE SATURATION/HEMATOCRIT MONITOR | Dec 27, 1990 | Substantially Equivalent |
| K902631 | COBE ICU CONVERSION KIT | Dec 17, 1990 | Substantially Equivalent |
| K902437 | COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER | Dec 17, 1990 | Substantially Equivalent |
| K904566 | NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER | Dec 12, 1990 | Substantially Equivalent |
| K902758 | COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC | Aug 23, 1990 | Substantially Equivalent |
| K902759 | COBE CLOSED WOUND DRAINAGE KIT | Jul 18, 1990 | Substantially Equivalent |