FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
K Number: K014303
·
Decision Mar 26, 2002
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
13
Review Days
85
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Basic Information
- Device Name
- JOSTRA RETROGRADE CARDIOPLEGIA CANNULAE
- K Number
- K014303
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jostra AG
- Date Received
- December 31, 2001
- Decision Date
- March 26, 2002
- Product Code
- DWF
- 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 |
|---|---|---|---|
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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Other Clearances by Jostra AG
| K Number | Device Name | ||
|---|---|---|---|
| K020983 | JOSTRA SUCKERS, MODEL JS | Jan 30, 2004 | Substantially Equivalent |
| K030264 | QUANDROX SAFELINE HOLLOW FIBER MEMBRANE OXYGENATOR, MODEL HMO 2030 | Feb 26, 2003 | Substantially Equivalent |
| K020784 | JOSTRA SINGLE STAGE VENOUS RETURN CATHETERS | Jan 9, 2003 | Substantially Equivalent |
| K023132 | JOSTRA MECC SYSTEM | Dec 17, 2002 | Substantially Equivalent |
| K022022 | JOSTRA VENT CATHETERS, MODELS LV & HKV | Sep 11, 2002 | Substantially Equivalent |
| K020515 | JOSTRA ANTEGRADE CARDIOPLEGIA CANNULA | Apr 24, 2002 | Substantially Equivalent |
| K013944 | JOSTRA DUAL STAGE VENOUS RETURN CANNULAE | Feb 11, 2002 | Substantially Equivalent |
| K013939 | JOSTRA FLOWPROBE FP-32E | Dec 14, 2001 | Substantially Equivalent |
| K012774 | JOSTRA ARTERIAL PERFUSION CANNULAE | Nov 16, 2001 | Substantially Equivalent |
| K012617 | JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... | Nov 6, 2001 | Substantially Equivalent |