FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDEON ASCENDING BALLOON CANNULA (ABC)
K Number: K001371
·
Decision Jul 7, 2000
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
6
Review Days
67
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Basic Information
- Device Name
- CARDEON ASCENDING BALLOON CANNULA (ABC)
- K Number
- K001371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cardeon Corp.
- Date Received
- May 1, 2000
- Decision Date
- July 7, 2000
- 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 Cardeon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K042156 | CARDEON COBRA CATHETER | Oct 6, 2004 | Substantially Equivalent |
| K024058 | MODIFICATION TO CARDEON AEGIS CATHETER | Dec 30, 2002 | Substantially Equivalent |
| K022042 | MODIFICATION TO CARDEON ASCENDING BALLOON CANNULA (ABC) | Sep 3, 2002 | Substantially Equivalent |
| K022174 | MODIFICATION TO CARDEON AEGIS CATHETER | Jul 29, 2002 | Substantially Equivalent |
| K013593 | CARDEON AEGIS CATHETER | Jun 24, 2002 | Substantially Equivalent |