FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
K Number: K994171
·
Decision Apr 27, 2000
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
7
Review Days
139
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Basic Information
- Device Name
- MEDTRONIC AORTOCORONARY SHUNT AND SEPARATELY PACKAGED ARTERIOTOMY CANNULAE
- K Number
- K994171
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medtronic Cardiac Surgical Products
- Date Received
- December 10, 1999
- Decision Date
- April 27, 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 Medtronic Cardiac Surgical Products
| K Number | Device Name | ||
|---|---|---|---|
| K022272 | MALLEABLE SINGLE STAGE VENOUS CANNULA, MODELS 68112-68140 (15 TOTAL CODES) | Jan 8, 2003 | Substantially Equivalent |
| K013013 | MEDTRONIC DLP ARTERIAL CANNULA WITH 3D TIP - 22 FR. | Dec 4, 2001 | Substantially Equivalent |
| K012143 | 24 FR. LEFT HEART VENT CATHETER WITH PRESSURE MONITORING LINE, MODEL 12524 | Oct 24, 2001 | Substantially Equivalent |
| K010737 | SELECT CAP ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODEL 78818,78820,78822,78824,78918,78920,78922,78924 | Apr 4, 2001 | Substantially Equivalent |
| K000776 | MEDTRONIC DLP ARTERIAL CANNULAE WITH 3D TIP | Feb 7, 2001 | Substantially Equivalent |
| K000274 | EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA WITH GUIDEWIRE | Feb 10, 2000 | Substantially Equivalent |