FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBE SMARXT TUBING AND CONNECTORS
K Number: K981613
·
Decision Oct 26, 1998
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
20
Applicant Total
43
Review Days
173
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Basic Information
- Device Name
- COBE SMARXT TUBING AND CONNECTORS
- K Number
- K981613
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4390
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cobe Cardiovascular, Inc.
- Date Received
- May 6, 1998
- Decision Date
- October 26, 1998
- Product Code
- DWE
- 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 |
|---|---|---|---|
| DWE | Tubing, Pump, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Cobe Cardiovascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
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| K042473 | COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM | Nov 19, 2004 | 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 |