FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
K Number: K042473
·
Decision Nov 19, 2004
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
43
Review Days
67
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Basic Information
- Device Name
- COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM
- K Number
- K042473
- Device Class
- FDA class 1
- Clearance Type
- Abbreviated
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cobe Cardiovascular, Inc.
- Date Received
- September 13, 2004
- Decision Date
- November 19, 2004
- Product Code
- JQC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Cobe Cardiovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050111 | SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG | Mar 8, 2005 | Substantially Equivalent |
| K040184 | DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER | Feb 26, 2004 | Substantially Equivalent |
| K033641 | SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 | Dec 11, 2003 | Substantially Equivalent |
| K030462 | COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 | Mar 6, 2003 | Substantially Equivalent |
| K021830 | SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM | Jul 2, 2002 | Substantially Equivalent |
| K011835 | COBE REVOLUTION | Feb 12, 2002 | Substantially Equivalent |
| K013480 | COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR | Nov 16, 2001 | Substantially Equivalent |
| K012763 | SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM | Nov 15, 2001 | Substantially Equivalent |
| K001509 | STOCKERT V172 SERIES VENOUS FEMORAL CANNULAE | Oct 26, 2001 | Substantially Equivalent |
| K012898 | MODIFICATION TO: CSC14 BLOOD CARDIOPLEGIA SYSTEM | Sep 17, 2001 | Substantially Equivalent |