FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ESTECH AORTIC EASY FLOW CANNULA
K Number: K060101
·
Decision May 10, 2006
Classifications
1
FEI Numbers
104
Registration Numbers
104
Same Product Code
400
Applicant Total
8
Review Days
118
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Basic Information
- Device Name
- ESTECH AORTIC EASY FLOW CANNULA
- K Number
- K060101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4210
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Endoscopic Technologies, Inc.
- Date Received
- January 12, 2006
- Decision Date
- May 10, 2006
- 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 Endoscopic Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053326 | ESTECH COBRA ELECTROSURGICAL UNIT & CABLE | Jan 6, 2006 | Substantially Equivalent |
| K053100 | ESTECH COBRA BIPOLAR SYSTEM | Dec 19, 2005 | Substantially Equivalent |
| K946105 | ELECTROSURGICAL CUTTING & COAGULATION DEVICE & ACCESSORIES | Apr 6, 1995 | Substantially Equivalent |
| K945978 | TUBING, NONINVASIVE | Jan 11, 1995 | Substantially Equivalent |
| K945979 | TROCAR/CANNULA | Dec 21, 1994 | Substantially Equivalent |
| K924057 | DISPOSIBLE ELECTRO COAGULATION PROBE | Mar 11, 1994 | Substantially Equivalent |
| K922685 | TROCARS | Apr 5, 1993 | Substantially Equivalent |