FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
K Number: K900105
·
Decision Mar 22, 1991
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
26
Applicant Total
77
Review Days
437
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Basic Information
- Device Name
- COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC
- K Number
- K900105
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Cobe Laboratories, Inc.
- Date Received
- January 9, 1990
- Decision Date
- March 22, 1991
- Product Code
- LKN
- Advisory Committee
- Unknown
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LKN | Separator, Automated, Blood Cell And Plasma, Therapeutic | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LKN), ordered by most recent decision date.
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AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike and Luer Adapter
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FDA 510(k)
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Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Spectra Optia Apheresis System
FDA 510(k)
FDA Unclassified
·Unknown
Other Clearances by Cobe Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K923272 | COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR | May 11, 1993 | 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 |
| K902671 | COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER | Jul 17, 1990 | Substantially Equivalent |